chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 1st dose in left arm, noticed burning pain all down my left side, with significant pain about 2 inches beneath every joint on my left side. Pain continued to worsen up to the point of my seeing my PCP on March 29th. Was prescribed Gabapentin 100mg/2xdaily for neuropathy.   Had my second shot scheduled for that same afternoon. After receiving the 2nd dose in my right arm, I noticed a similar reaction down my right side beginning the next morning (3/30). Started taking the Gabapentin and noticed improvement by April 3rd. Was only prescribed 10 day supply and have been trying to only take 1 tablet daily, but the pain breaks through when I do that. My PCP has now prescribed 100mg 2x/daily and 200mg/bedtime for the coming month and has stated that ongoing pain will require a neurology consult.
Patient received imz at 12:30pm waited for 15 minutes; left; returned 15minutes later with symptoms: sweat,clammy,rapid heart, short of breath, faint, dizzy, nervous, . We had her sit down, drink water, applied wet towels to neck and head. she felt better 15 minutes later and left. I called and checked the patient at 2pm and she said she felt better except for a headache.
Muscle pain and tightening, significant fatigue, fever, chills lasting overnight. Muscle pain, fatigue and brain fog lasted for 2 days after vaccination but improved each day. No medications taken.
Patient received the vaccine and waited approximately 15 minutes in the waiting area before getting up.  While he was walking around with his significant other, he felt faint, everything went dark, and his wife sat him down on the floor.  Patient did not get hurt.
running nose; PCR Covid Positive; PCR Covid Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Nov2021 (Lot number: 8B21-2A) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 2013 (ongoing); "allergies" (ongoing), notes: since 5 years old; "Mild asthma" (ongoing), notes: since 5 years old. Concomitant medication(s) included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM] taken for hypothyroidism (ongoing); ALLEGRA taken for allergy to animal (ongoing). Vaccination history included: Moderna (Dose 1, Anatomical site of injection: arm, Route of administration: Intramuscular, Batch/Lot number: Moderna 4A21A), administration date: 11Mar2021, when the patient was 39 years old, for COVID-19 immunization; Moderna (Dose 2 , Anatomical site of injection: arm, Route of administration: Intramuscular, Batch/Lot number: Moderna 8B21-2A), administration date: 08Apr2021, when the patient was 39 years old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Jan2022, outcome "unknown" and all described as "PCR Covid Positive"; RHINORRHOEA (non-serious), outcome "unknown", described as "running nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (11Nov2021) sars-cov-2 total ab value 1615,0 standard 0.0-0.7, notes: SARS-Cov-2 total interp value positive standard -negative; sars-cov-2 test: (12Jan2022) negative, notes: was negative on 10Jan2022 runny nose; (17Jan2022) positive.  Clinical course: No specific relevant test for thromboembolic events with thrombocytopenia. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Noticed welts on skin increasing in size. Increased itching. Rapid Pulse. Patient received care from primary care physican who prescribed prednisone and Benadryl.
Received 2nd vaccine  3/9  one week after vaccine developed. Multiple kanker  sores in right side inner oral mucosa and right side facial swelling temp 98.4 improving today facial swelling and lesions are decreasing.  We contacted dentist and primary care physician by phone sent pictures of mouth to dentist. Received advice for treatment.
Pt seen in ER 1 day following administration of Pneumovax Right arm SC. Dx. cellulitis and placed on Abx.
Initial information has been received from a whole sale representative, as told by a customer, and follow up information has been received from a healthcare worker, concerning a 65 year old male, with unknown medical history, who on 27-JUN-2006 was vaccinated (route unknown) with a first dose (0.5mL) of Pneumovax 23 (Lot # 651328/1046P). Concomitant therapies may have included ROCEPHIN. Initial information received from the whole sale representative reported that the customer indicated that "we heard the patient reacted to Pneumovax 23 and that the patient had a rash." Initially the clinical outcome of the patient was not provided. Follow up information from the healthcare worker indicated that the next day, on 28-JUN-2006, the patient's arm was swollen and then became swollen, red and warm from shoulder to the elbow. He was treated with warm compresses and the red, swollen, warm arm resolved within 1 week. The reporter indicated that all serious criteria was no. However, she requested that a lot check be done on the lot, because she was not using it on any other patients. She also noted that she was "afraid this might happen to other patients". A lot check has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information has been requested.
swollen lymph node in the neck; Sore throat; some muscle ache; he is stuffy and wormy/he generally wasn't feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), administration date 14May2021 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph node in the neck"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat"; MYALGIA (non-serious), outcome "unknown", described as "some muscle ache"; MALAISE (non-serious), outcome "unknown", described as "he is stuffy and wormy/he generally wasn't feeling well".  Additional information: patient had a little bit of swollen lymph node in the neck, that was Saturday on Sunday I don't know he generally wasn't feeling well, he thought he was coming down with something Monday he was doing okay for the most part but then Tuesday and Wednesday, he has a sore throat and then today still the sore throat but now having some muscle ache and he is stuffy and wormy so you know it is like the days later he is still experiencing some side effect, is that normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have been on prednisone for the arthritis and breathing treatments for the shortness of breath.
Back of the left arm on the tricep swelled up with a burning aching pain. Patient states it felt hot to the touch. Occurred about 12 hours after the shot, and it lasted for about 24 hours. Patient took TYLENOL for the swelling, which seemed to help some. Patient was vaccinated 31 days before at previous facility with both FLUVIRIN and PNEUMOVAX.
Significant lower abdominal pain, right side.  Probable Appendix.   No diagnostic testing was requested or conducted.  I had 101 degree fever 12-36 hours after the vaccine injection.  This was not unexpected and this was relieved by Tylenol.  Abdominal pain started about 48 hours after injection and persisted for day; No fever or other related appendix symptom.   Went to bed with some pain, and awoke the next day with no pain.   No long term effect.
One hour after vaccine administration patient c/o severe stiffness in the right arm where vaccine was administered. The next day she came back and she had a rash that banded around her arm below the injection site and she stated that she had flu-like symptoms the previous night.
I had runny nose before and after the second shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 03May2021 (Batch/Lot number: unknown) as dose 2, single and administration date 08Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious) with onset 29Apr2021, outcome "unknown", described as "I had runny nose before and after the second shot.".  Additional Information: The event onset latency was 21 days after vaccination. Patient just took the second shot but before patient took the second shot. The patient had runny nose. So is that ok. patient went to take second shot already. Today is Tuesday, Monday, yesterday patient took the second shot. patient had runny nose before and after the second shot. The runny nose started last Friday (29th of April; Thursday). patient went to take the second shot. Consumer stated, "I want to know is this ok because I have friend who told me I shouldn't to go to take the second shot because I have runny nose but I took it already, already had it." Consumer was informed about the role of Pfizer Drug Safety and Medical Information Department for the concern and was provided with the contact# for Pfizer Medical Information as # Option 3, and was informed that the department is open from Monday to Friday, from 8 am to 8 pm and 9 am to 3 pm on Saturday and Sunday as per time zone. When asked for permission to probe questions, consumer stated, "No, that is okay because I do not have the time." When probed for LOT# and Expiration date, consumer stated, "What is the LOT#. I don't know. No, I couldn't find it." Further probing could not be done as consumer was unwilling to complete the report. Hence, limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HYPOXEMIA  3/11/2022 &  3/17/2022  -- RECURRENCE OF SAME SYMPTOMS
Injection arm was really sore until around 4-5PM - a lot worse than the first vaccine I received and I had a 4/10 headache the whole day. Other symptoms started about 12 hours later which included: Whole body was sore and weak Sluggish/exhausted  About 13-14 hours after injection: Sudden chills  Treatments: I took two ibuprofen and took a warm shower and I was completely fine afterwards.
1.  Tinnitus that will not go away and is getting more pronounced each day.  2.  Fingernails tingling and sensitive - seems to be subsiding.
60x45 mm (R) upper arm appearing 24 hrs after injection of DTaP. Local reaction.
Myalgia Chills, states had spotting for 5 days after last vac and never had a period since then Narrative:
Two weeks after second dose of Moderna he woke up very ill.  Fever, nausea, no appetite, weakness, aching, and has since lost 35 lbs, continues to be very weak, no appetite and is very depressed and is about to give up hope and feels like he is dying.  Encouraged him to see dr. sooner than his scheduled June 25 visit and lab work.
Swelling on the right side of my face. It started about 10 days after the vaccine shot. I don't remember much fever, though I did miss ~2 days of work. When the swelling was at its worst, my right eye was almost shut, but there was little or no pain. I went to a local urgent care clinic, and they gave me a COVID test, which was negative. Then I called my regular physician's office. He could not see me, but another doctor did.  Doctor thought it might be just an ordinary bacterial infection and not a result of the vaccine.
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of PNEUMOVAX 23 (Lot # unknown). The pharmacist reported that a colleague administered PNEUMOVAX 23 to the patient who had received it one year prior (date unknown). After the administration, the patient developed redness and swelling at the injection site. It is unknown if the patient sought medical attention. Follow up information has been received from the pharmacist concerning the 72 year old female patient with multiple myeloma, stage I who on 19-JUL-2010 at 17:15 was vaccinated with the second dose of PNEUMOVAX 23 SC. Patient's arm became swollen and red the day after administration. On 20-JUL-2010 at 08:00 the patient developed cellulitis. She had last PNEUMOVAX 23 one year previous and had reaction "now". The patient felt better after 2 doses of KEFLEX 500 mg (take one three times daily). On unspecified date, the patient recovered from cellulitis. The cellulitis, swollen and red in arms was considered to be an other important medical event by the reporter. Additional information is not expected.
Headache, fatigue and run-down feeling.  By Saturday morning (vaccine given Wed evening) I had recovered from the side effects.
Moderna COVID-19 Vaccine EUA  Fever for 24 hours; max temp 102; temp stayed at 102 even after taking advil; severe chills and body aches for 18 hours--pain was too severe to be able to sleep; lightheaded 24 hours; fatigue for 3 days; headache for 4 days; Sore arm, unable to lift arm second day after vaccine (but that pain was less severe than body aches)
Administration error: A 38-year-old male patient receives a second booster dose of the Pfizer vaccine. According to the current guidelines, in order to receive said dose, he should be over 50 years of age and suffer from some immunocompromised condition.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot numbers, expiration dates, doses and routes of administration were not provided). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine administered on 3/23/2021 at 2:55 PM.   Felt a little tired a few hours later but that is not unusual on any given day. On 3/24/2021 at around 1 PM, I felt a little chilly but had no fever. Around 3 PM, I left my desk and took 1 Aleve and reclined on recliner with blanket over me and fell asleep for about 2 hours. Upon awakening, the tops of my feet (wearing sneakers) and tops of my hands were extremely itchy. No rash visible on either.  I applied lotion to tops of both feet and hands and left uncovered.  I applied some additional later. By the morning of 3/25/2021, the itchy feeling was gone.  No other effects since this condition.
This spontaneous report as received from a nurse practitioner refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX, subcutaneously, lot # L021216, expiry date 21-JAN-2017 and lot # L025208, expiry date 07-JUL-2017 (strength, dose and site of administration were not reported). The temperature excursion was to 41.2 degrees Fahrenheit for 5 hours 21 minutes in February 2016. There were no reports of any adverse effects. Additional information has been requested.
Symptoms following 1st dose (5/28/2021 08:55): Metallic taste within 15 minutes from injection.  Neck stiffness and moderate jaw pain started within 30 minutes.  The following day, had arm soreness which was relieved by use.   Headache for next few days.  Four days from injection, started four days of feeling ill with fatigue, sore lymph nodes throughout body, trouble concentrating, achiness, and dull pain in center of chest.  Chest pain lasted about 2 weeks.  Lymph node soreness lessened until only one (behind left ear) was still sore at the time of the 2nd dose.  Symptoms following 2nd dose (6/18/2021 09:00): Bitter taste within 15 minutes from injection.  Minor jaw pain the same day.  In the middle of the night, woke up violently shivering although room was warm.  Mild tenderness at injection site and mild headache for a few days.  Three and a half days from injection, developed sore throat, runny nose, and fatigue which lasted for about 5 days.  One week from vaccination, went to urgent care clinic to get COVID-19 PCR test (negative) to rule out symptoms being caused by Delta variant.  As of today (7/1/2021), continue to have occasional mild soreness in lymph node behind left ear.
She reported to start to feel unwell around 9 pam - achey, tired, sore right arm & feverish.  11 pm Temp 102, by midnight was 104.  She took a bath and tylenol around 1 am and temp only fell to 102.  Woke the next am and was again 104.  Breathing was fine.  Friday 1/15/2021 by 2 pm she was still having fevers to 103.6 and was in contact with the experts she is seeing.  I did not hear back again until 10 am Saturday 1/16/2021 when the fever had finally gone and she was still with right arm pain and a little headache. As of today 1/19/2021 other than her symtpoms for which she is seeing specialty care, she is back to baseline.
Itching and single hive at injection site. Tx with BENADRYL and.
Area of increased erythema 15 centimeter by 13 centimeter left upper extremity.
REDNESS/SWELLING AT INJECTION SITE / WHOLE UPPER ARM RADIATING TO ELBOW BY THE NEXT DAY / STIFFNESS IN NECK.
The pt experienced soreness of the arm and had loss of function for 2 days. After the 2nd dose the pt had pain the the small joints of hands that lasted up to 4 weeks. The pt has persistant morning stiffness of hands.
Administrated the Jynneos vaccine after the BUD to two patients; Case reference number US-BN-2023-000452 is a spontaneous case report initially received on 09-Mar-2023 from a pharmacist (reference number: USBAV23-0397) and concerns two patients of unknown demographics.   The patients' medical history and concomitant medication details were not provided.  On 07-Mar-2023, one (out of two) patient was vaccinated with a dose of Jynneos vaccine (batch number: FDP00005; expiration date; unknown) after beyond use date (BUD) (explicitly coded as 'expired vaccine used'), at an unknown dose, route or site of administration, for smallpox/monkeypox prophylaxis.  On 08-Mar-2023, the second patient was vaccinated with a dose of Jynneos vaccine (batch number: FDP00005; expiration date; unknown) after BUD (explicitly coded as 'expired vaccine used'), at an unknown dose, route or site of administration, for smallpox/monkeypox prophylaxis.  At the time of initial report, it was unknown if the patients experienced any adverse event due to Jynneos vaccination.  Additional information received from Bavarian Nordic on 10-Mar-2023 included local case ID number.; Reporter's Comments: This case concerns two patients of unknown demographics who reportedly received expired Jynneos vaccines on 07-Mar-2023 and 08-Mar-2023 for smallpox/monkeypox prophylaxis. No associated adverse events were reported. Expired product administered is listed per company convention. The patients' medical history and concomitant medication details were not provided. Expired product administered is not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: This case concerns two patients of unknown demographics who reportedly received expired Jynneos vaccines on 07-Mar-2023 and 08-Mar-2023 for smallpox/monkeypox prophylaxis. No associated adverse events were reported. Expired product administered is listed per company convention. The patients' medical history and concomitant medication details were not provided. Expired product administered is not related to Jynneos, but to a human factor. The case is non-serious.
Patient reports rash/hives all over body, began on 11/8/06 (2 days after receiving vaccine).
Pain (not just soreness) at injection site, fever 101, chills, aches, headache, cough
Tachycardia that resolved after about an hour after vaccine. Fatigue and severe arm pain at injection site for 3-4 days. Severe arm pain / injection site pain required Aleve for about 3 days.
About 8 hours after receiving the 2nd shot of Zoster my face looked swollen.  I was breathing normally. I took a Benadryl. Did not seek medical treatment. My face look like I had gained 20 pounds.  This side effect did not happen with the first shot. The swollen face did not her worse, it was 90% back to normal by the next morning. I did feel malaise and achy that next day all day.
Pt broke out in hives on back & chest, 10 mins p/vax; pt was given DPH; hives began to resolve; pt was watched for a total for 30 mins w/no further reactions noted;
Skin- maculopapular confluent rash all over body. MMR? side effect . Pt c/o increase fever not eating well. C/o diarrhea runny (differ odd colors) c/o tired cranky c/o rash on face spreading to back feet legs all over getting worse
developed inflammatory joint pain and swelling 7-8 days after vaccine # 2  elevated sed rate and crp  ultimately positive for scleroderma antibodies (positive ANA)
covid at the end January; covid at the end January; This is a spontaneous report received from a contactable reporter(s) (Physician) (epidemiologist) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "covid at the end Jan2022". The patient had done well, had had the 2 Pfizer shots and the booster, and subsequently had COVID at the end Jan2022, and she developed a pulmonary embolism.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. The case will be reevaluated should additional information become available.
Injection site pain; sore arm; muscle aches; fatigue; fever; headache; This is a spontaneous report from a contactable consumer (patient herself). A 25-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EK9231, expiration date: unknown), via an unspecified route of administration on the left arm on 31Dec2020 at 15:45 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. The patient had no known allergies; no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Jan2021, the patient experienced injection site pain, sore arm, muscle aches, fatigue, fever, and headache. The reporter assessed the events as non-serious. The patient did not receive any treatment for the events. The patient was recovering from all the events.