chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse via a Pfizer Company representative. This nurse reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age and race/ethnicity received PREVNAR 13 via an unspecified route of administration in the right arm on an unspecified date at 0.5 ml single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced red spots on the arm where she got the pneumonia shot two days before. The patient did not have any other symptoms like fever, she was not warm or anything like that. The patient had a full checkup, the patient's blood pressure was slightly elevated (150/80 mmgHg) but everything else was fine, they examined her arm and it showed some redness on her right upper arm where she got the injection and it did not appear to be cellulitis, so the treatment that they gave to her for red spots was prednisone 20 mg, 3 tablets daily, for 3 days. Outcome of the events was unknown. Causality assessment was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017165913 same reporter/suspect product, similar event, different patient.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender with no drug reactions or allergies and no pertinent medical history who on 16-JAN-2013, was vaccinated intramuscular on right upper arm with, 0.5 ml PNEUMOVAX23 (lot }# not provided). Other suspect therapies included subcutaneously on right arm live ZOSTAVAX (dose and lot # not provided) on 16-JAN-2013. No concomitant medications were reported. The nurse stated that on 16-JAN-2013 patient experienced right shoulder pain and stiffness since that date. The patient was administered a 0.5 ml dose of PNEUMOVAX intramuscular ly and a single dose of ZOSTAVAX subcutaneously at separate locations in the right upper arm. The patient sought medical attention called the nurse. The patient has used hot and cold compresses, as well as TYLENOL, but the symptoms have not improved at the time of the report. No further information provided. The outcome of right shoulder pain and stiffness was reported as not recovered/not resolved. The relatedness for right should pain and stiffness was unknown for PNEUMOVAX23 and ZOSTAVAX. Additional information has been requested.
Body aches; headache; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the left arm on from 04Jan2021 13:15 (lot number Ek9231 and expiry date unknown) at single dose for Covid-19 immunization in a hospital. Medical history included depression and insomnia. The patient has no COVID prior vaccination. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), melatonin, escitalopram oxalate (LEXAPRO), drospirenone, ethinylestradiol betadex clathrate (YAZ), amitriptyline; all from unspecified date for unspecified indication. The patient did not receive other vaccine in four weeks. On 05Jan2021 12:00 AM, the patient experienced body aches, headache, and fatigue. The patient was not COVID tested post vaccination. The patient did not receive treatment due to the events. The outcome of the events body aches, headache, and fatigue was recovered in Jan2021.
At school, flu vaccine given. Pt went to classroom school nurse reported 20 mins later-patient started having hives breaking out all over arms/backs/chest/neck. She gave BENADRYL 75mg to patient. She states "He has allergies to some things but never to flu vaccines". Hives/rash faded parent pickup going to doctor.
10x11 cm erythematous macular area around site of shot with suggestion of central vesiculation starting 1 day after vaccine. Less severe local reaction 5/6
Two weeks after receiving my second Moderna shot, my mouth broke out with 10 sites of Herpes Simplex cold sores under my tongue, which lasted through the month of March 2021; after a week or so of reprieve, the same number broke out again, now in the month of April, 2021. I have previously had mouth sores, however NOT frequently,  and since this break out is so extreme and lasted so long, and is now repeating itself, I thought I'd report this just in case other people are as well.
This reaction; have been waking up at 12 o'clock or 1 o'clock and be wide awake; A spontaneous report was received from a Consumer concerning a female patient (age not mentioned) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced reaction and  have been waking up at 12 o'clock or 1 o'clock and was wide awake.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Lot batch: Unknown) via unknown route ,for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced reaction (not specified) and  the patient have been waking up at 12 o'clock or 1 o'clock and was wide awake.  Lab data was not provided.  Treatment was not taken by the patient.  Action taken with mRNA-1273 in response to the events was Unknown.  The outcome of events-reaction and waking up at 12 o'clock or 1 o'clock and  wide awake -was Unknown.
local react: 2 days p/inject it became hard & swollen 24MAR93; on 31MAR93 sent to school nurse for bandaid had a quarter size abscess lt arm; also dx & treated for scabies.
Information has been received from a Registered Nurse concerning a 51 year old male patient with mild hypertension, diabetes and high cholesterol with no drug allergies and no illness at the time of vaccination who on 16-JUN-2009 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 659922/1667U), expiration date 23-AUG-2009, 0.5ml, subcutaneously into left arm at 1:00 p.m.. Concomitant therapy included tetanus toxoid, COREG, aspirin, PRAVACHOL, AVANDIA, lisinopril (manufacturer unknown) and allopurinol. On 17-JUN-2009 at 10:00 a.m., the patient experienced a rash at the top of the unspecified arm with edema, slowly resolving over a week. On approximately 19-JUN-2009, 3-4 days after the shot, the patient was riding in a limo, fell asleep and drool was coming out of his mouth. The son was hysterical.  Went to an emergency room and was checked out, blood count was negative. Later AVELOX was prescribed by physician for possible cellulitis. At the time on the report on 23-JUN-2009 the patient had not recovered. No further information is available.
fever 102.9, chills, sore throat, headache, full body aches, rash  lasted 3 days
I stayed for my observation period, got home within  minutes (distance from pharmacy is close) and was talking to my husband when my heart started erratic heart palpitations for approximately 10 seconds straight. My body tingled, face got hot and flushed and got dizzy. Got an appointment with MD and she sent me to the ER immediately. By the time the ER got me to the back and did an EKG, instant read, it wasn't doing it at that time and they sent me home. (they didn't monitor, it was preformed in seconds) I've been dizzy ever since 07/13 to the point of not feeling stable when walking and driving.
left side of my face looked swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (left side of my face looked swollen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included AMLODIPINE, POTASSIUM and OLMESARTAN for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced SWELLING FACE (left side of my face looked swollen). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and IBUPROFEN at a dose of UNK dosage form. At the time of the report, SWELLING FACE (left side of my face looked swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No new information was provided
Chronic Tinnitus  was noticed about a week after 2nd shot. In right ear only. Not pulsating. Not taking any meds associated with tinnitus.
swollen gland armpit night of 2nd vaccine, fatigue next day, chills and hot flashes evening, while sleeping tried? to get to bathroom directly connected to bedroom to splash cold water on face, couldn't locate faucet or light switch, woke up on the floor. I know I passed out as I have bruise on butt where I hit the night table. Do not know if I was dreaming, then tried to get up or I had fallen while getting up.
This is a spontaneous report from a contactable pharmacist. A 78-year-old female patient received PREVNAR 13 (lot N34936, expiry date 31Oct2017, NDC number 0005-1971-02) intramuscular, in left deltoid, on 26Oct2016, at about 17:00, at 0.5 ml single, for pneumonia prevention. The patient medical history was not reported. The patient's concomitant medications were not reported. Since an unspecified date in Oct2016, after vaccination, the patient experienced diarrhea, extreme tiredness, weakness, loss of appetite, sore dull pain in her arm, froggy throat.  The patient mentioned these side effects to her doctor but felt they were not significant. The events had not yet resolved at the time of report.
rash to face; tingling to face (intermittent); feels like high histamine; chills; fever; mouth burns; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash to face), PARAESTHESIA (tingling to face (intermittent)), PRURITUS (feels like high histamine), CHILLS (chills) and PYREXIA (fever) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 07-Apr-2021, the patient experienced RASH (rash to face), PARAESTHESIA (tingling to face (intermittent)), PRURITUS (feels like high histamine), CHILLS (chills), PYREXIA (fever) and ORAL DISCOMFORT (mouth burns). On 09-Apr-2021, CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, RASH (rash to face), PARAESTHESIA (tingling to face (intermittent)), PRURITUS (feels like high histamine) and ORAL DISCOMFORT (mouth burns) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medicine has been reported by reporter   Reporter did not allow further contact
9/21/07 at 0200 - 1535 woke up. Nauseated. "Felt like intestines were on fire" Soft bowel movements x4 (0200-0330. States felt SOB at 0600-1000. Talked to nurse at Dr. no openings w/doctor offered N.P. She declined. States not SOB at this time. Still naueseated. Advised to follow up with Dr. and report to ER if SOB.
Patient said there was some itching after the injection. The site was not red at the site 15 minutes after injection. She said there is a small red bump that is warm to the touch at the injection site and is still present 2 days later.
pain & stiffness in joints of fingers, wrists, knees & feet over a period of about 2 wks; dx by MD as reactive arthritis due to vax;
December 23, 2020, at approximately, 1645 patient noted right eye numbness that tingled into right cheek. At 1730, looked in the mirror and noted no movement in muscles on right side of face. Could raise right eyebrow, but right eyebrow and below numbness and no movement. Patient spoke with physician at Public Health Department and it was recommended patient go to Primary Care to see provider NP. Then at approximately, 1920 went to the local Emergency Department and was seen by Dr. in the ER department. Dr. consulted with on call neurologist.  Patient  states she was diagnosed with Bells Palsy and given oral steroids ("three pills), then started a Medrol Dose Pak the next morning. As of today, December 28, 2020 patient reports "Face and eye area feel normal. My mouth is not drooping. I have at least 50% of my movement back." Patient continues to take Medrol Dose Pak. On day 4 of Medrol Dose Pak has 3 more days. Emergency Department recommended patient follow up with pcp in 5-7 days.
Patient's wife called the next day after injection to report he was having injection site redness & swelling, and the area was warm to the touch. She noted that the swelling had extended to his elbow today (>24 hours post injection). He has been icing the site and taking ibuprofen for pain. I suggested to keep icing and alternating acetaminophen with ibuprofen and to monitor for improvement, and if no improvement or worsened symptoms within next 24-28 hours, to contact physician.
About 2 minutes after injection, I had a sudden rush of warmth throughout my body starting in my abdomen then causing my pulse to feel like it was pounding out of my neck. Got light headed. EMS came and my blood pressure raised to 155/95 and my pulse was up in the 150s and I was shaking.  Started to go down but felt crappy for over 2 hours. Happened again 30seconds after the second injection. Pulse up to almost 160. 02 stats stayed normal. Post first injection had sore arm and lots of fatigue and brain fog. Following the second injection 12 hours post started having nausea, and diarrhea. Continued to have joint pain, muscle aches, headaches for days, and my lymph nodes swelled up and were extremely painful.
The day after receiving my second dose, I noticed a lump in the area where my armpit and left breast meet. I saw a doctor. She followed me for two weeks. It was painful while it was there. At my two week f/u, the doctor was not able to find the lump and I noticed the pain had decreased. Around 4 1/2 months after receiving my vaccine, I woke up at 04:00PM ET and realized my heart rate was very high. I lay down for ten minutes, but my heartrate did not decrease any. I checked my pulse/ox it was 177 bpm. By the time I got to the ER, my heartrate was at 210. I was admitted with A-fib. I had 2 EKG's, 2 CTC's with contrast, a cardio echo and a cardio stress test. Everything came back showing that everything was normal. After I left the hospital, I was prescribed Eliquis and Cardizem. I am to continue taking them until I meet with cardiologist in September. I did a sleep study and now I need to be on a C-Pap.
Patient fully vaccinated 1/23/26.  COVID-19 symptom onset 6/28/21, COVID-19 test positive at Maples Nursing Home 6/30/21, patient hospitalized for COVID-19 infection at Sturdy Memorial Hospital 7/1/21 and required oxygen support, Decadron, and Remdesivir therapy.
On 8/11/2014 Employee's forearm had a raised bump with inflammation surrounding area.  Area spread as each day passed.
This spontaneous report as received from an office manager refers to a patient of unknown age. The patient's medical history, current conditions and concomitant medications were not reported. On 28-AUG-2017, the patient was vaccinated with an expired dose of RECOMBIVAX HB lot # L000877 and expiry date: 22-JUN-2017. No adverse effects were reported and no temperature excursion was reported prior to administration. There was no product quality complaint.
Patient developed a red lump on left leg that increased to 3 cm with a red ring/hot to touch & discomfort for patient. Hydrocortisone cream + oral antihistamine. Drew circle to track.
This spontaneous report as received from a nurse refers to a 3 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 26-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Onset of chills, fever, deep ache in bones of face, jaw, neck, upper arms, chest and back. Restlessness, pain in base of tongue, extreme dry mouth, stuffy nose.  Unable to sleep all night due to pain. Treatment so far, two Tylenol this AM. Outcome not yet determined.
The day after i had the vaccine, my bicep and my forearm muscle were red and hot and enlarged. I thought my muscle were going to explode from the pain. The net day i saw large amount of bruising in my under arm and my bicep. Its been a week, the bruising is decreasing, i still have pain if i want to straighten my arm or if i touch my muscles.
Information has been received from a medical assistant concerning a 23 year old female patient who on an unspecified date was vaccinated with three doses of RECOMBIVAX HB and failed to seroconvert. The outcome of the patient was not reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Pt received HPV9 #1 dose 8/3/16 (IM (L) Deltoid without discomfort/complaint). Pt returned 9/29/16 for 2nd dose HPV9, however reported swelling at the site of first dose. Staff and Dr examined area and discussed with mother and pt and decided to hold 2nd dose of HPV9 and observe area for improvement before going ahead with 2nd dose. Pt returns today 10/13/16 with area still swollen but now with serosanguinous drainage, pain at 8/10 at worse and approx dime sized open wound. Pt reports these changes happened Tue. 10/11/16. MSD Lot number M020103, Exp. 2/15/18. TX - Clindamycin 300 mg TID per Doctor.
PATIENT EXPERIENCED A FEVER THE NEXT DAY. PATIENT TREATED IT WITH TYLENOL AND HAS SINCE RECOVERED
received the (1st dose of) COVID-19 vaccine 5 days ago and tested positive; received the (1st dose of) COVID-19 vaccine 5 days ago and tested positive; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Device Type: Vial), intramuscularly on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the (1st dose of) COVID-19 vaccine 5 days ago and tested positive on 23Dec2020. PharmD asked if it's possible to administer Bamlanivimab to a patient who received the (1st dose of) COVID-19 vaccine 5 days ago and tested positive. Pharmacist mentioned that as Bamlanivimab was an EUA drug, they cannot go outside of the recommendations, and given that no information was available about its use after a dose of the COVID-19 vaccine, it is possible that Bamlanivimab may not be administered. Explained Pfizer MI is unable to provide a direct recommendation, was referred to the patient's Docton for guidance: Before receiving the next dose of the COVID-19 vaccine, and to clarify if Bamlanivimab should be administered. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: The reported  tested positive 5 days after COVID-19 vaccine is considered related to the administration of BNT162B2.
3/1 - just mild sorness at the injection site and minor fatigue 3/2- severe pain/ache in legs and a mild fever (100.2 oral) started in mildly in the morning but by 1pm was very uncomfortable. Treated with Ibuprofen (it took 2 pills - so 400mg total) before I could rest. After a 4 hour nap I woke up feeling much better. No fever and only minor aching in the legs.  3/3 - Woke up feeling normal
This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 68-year-old, elderly female patient. On 16-Oct-2018, the vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc that underwent temperature excursion [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019]. The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805013) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received from the reporter on 13-Nov-2018: The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The reporter refused to provide the patient's initials and date of vaccine administration. The narrative and case comment were amended accordingly.
Day after injection had raised, red, hard blotch at injection site. Slightly itchy. No temp. per pt. 5 days later pt reports all sx almost resolved. Feels fine.
Initial information received on 11-Sep-2018 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a 58 years old female patient who experienced hot, red and swollen, injection site hard knot and severe itching, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Food allergy and anaphylactic reaction. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the left deltoid. On an unknown date, the patient developed a non-serious the injection site in the left deltoid, became hot, red and swollen (vaccination site inflammation) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious injection site hard knot (vaccination site nodule) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious severe itching (vaccination site pruritus) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included no lab data.) Final diagnosis was severe itching, injection site hard knot and the injection site in the left deltoid, became hot, red and swollen. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for the injection site in the left deltoid, became hot, red and swollen, as Unknown for injection site hard knot and as Unknown for severe itching. List of documents held by sender: none.
Administered the wrong dose to patient. Patient received dose for 12+ (0.3 mcg/0.3 ml) instead of 5-11 dose (0.2 mcg/0.2 ml).
DEATH.  - Had Moderna booster shot on 11/17 12:00pm  - We did not hear from him  on 11/18... We believe he passed on 11/18. - Police found him dead on 11/19 8:31 floor next to bed. Death certificate says "cardiac arrest" has reason for death.
Itchiness of scalp, face, neck, upper chest without hives or rash.  Feeling of itchiness of ear canals and a sense of a little tightening of the throat.
After 4 1/2 - 5 hrs. post vaccination, stated develop weakness, dizziness, throat swollen low grade fever. BENADRYL 1 50 mg P.O. given at ED.