chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her pain is worse constantly and she can hardly use the opposite arm; even to touch the skin is extremely painful; her cubicular lymph node was swollen; the area between her neck and armpit has swelled up more and more; pain in between neck and armpit; pain goes into back; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (BNT162B2), dose 2 parenteral (reported as "injection") at the age of 66-years-old on 19Mar2021 (Batch/Lot number was not reported) as single dose in Arm Left for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received bnt162b2 (BNT162B2), dose 1 on an unspecified date for COVID-19 immunization. The patient received the first vaccine with no problem. She received the second vaccine on Friday 19Mar2021 and the next day, 20Mar2021 it felt like her cubicular lymph node was swollen. Every day since then, the area between her neck and armpit has swelled up more and more. Her pain is worse constantly and she can hardly use the opposite arm and even to touch the skin is extremely painful. This is on the opposite side from where she received the shot. The event "area between neck and armpit swelled up" started 20Mar2021 and is ongoing. It increases constantly and it is almost disabling it is in between medically significant and disabling. It has worsened. The event "pain in between neck and armpit" started the past Friday (Mar2021) and is ongoing. It is medically significant but almost disabling as she cannot use her right arm. This has worsened. The event "pain goes into back" started 2 days ago and is ongoing. This is medically significant and has worsened. Treatment was received for the events. The doctor gave her Toradol injection intramuscular and it did not effect anything and she has also taken Tramadol and Flexeril, a muscle relaxer, which did not effect anything. Her doctor has never seen anything like the symptoms she is experiencing. She had an X-ray done but she does not have the results yet as it was done yesterday (29Mar2021). The outcome of the events "her cubicular lymph node was swollen" and "even to touch the skin is extremely painful" was unknown while for the rest of the events was not recovered.  Relatedness to COVID 19 vaccine: area between neck and armpit swelled up, pain in between neck and armpit, pain goes into back - Related.  Information on the batch/lot number was requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Tachycardia resolved as patient was monitored ~20 minutes after influenza vaccine administration
Patient complained of diarrhea and stomach pain, patient called said it was getting better, stomach pain went away, still has a little diarrhea.
Chills; he doesn't feel well; he has a pain the most and we are worries that pain that he got in his chest, Muscle ache; Fever; he has a pain the most and we are worries that pain that he got in his chest, Muscle ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 24Dec2021 (Batch/Lot number: unknown) as dose number, unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; MALAISE (non-serious), outcome "unknown", described as "he doesn't feel well"; MYALGIA (non-serious), CHEST PAIN (non-serious), outcome "unknown" and all described as "he has a pain the most and we are worries that pain that he got in his chest, Muscle ache"; PYREXIA (non-serious), outcome "unknown", described as "Fever".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (14Jan2022): This is a spontaneous follow up report from a contactable consumer. This consumer reported in response to Non-HCP telephonic follow up activity which included that: Updated Information included: Primary Reporter's information.  The lot number for the vaccine , BNT162B2 was not provided and will be requested during follow-up.
Approximately 24 hours after the varicella vaccine the child ran a fever and had a seizure. He was taken to the emergency room. The seizure lasted about 5 minutes. ACT scan and lab work were done. Both were normal. Dr is ordering an EEG for 12/23/14.
can one get shingle from vaccine; felt warm yet not temp registered; rash on arm shot given; headache; This case was reported by a consumer via call center representative and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced headache. On 1st March 2020, the patient experienced rash. On 2nd March 2020, the patient experienced feeling of warmth. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the rash, headache, feeling of warmth and shingles were unknown.   It was unknown if the reporter considered the rash, headache, feeling of warmth and shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had rash on his arm, headache, felt warm, and asked can any one get shingle from vaccine. The patient was worried as the daughter in law was pregnant.
SWOLLEN AND PAINFUL AXILLARY, NECK AND CHEST GLANDS STARTED ON SAT 05/27/06. PT VOICED THAT SHE CALLED FOR ADVICE ON SAT WAS TOLD TO TAKE TYLENOL FOR PAIN AND IF SHE BECAME FEVERISH SHE SHOULD THEN GO TO E.R. PT VOICED TODAY SHE STILL HAS SWOLLEN GLANDS SLIGHTLY LESS THAN SAT NOT AS PAINFUL. TODAY PT VOICED SHE FEELS NAUSEATED AND TIRED. PT HAS BEEN USING TYLENOL CONSISTENTLY FOR PAIN.
Awoke with fever-12 hrs after vaccines, Seen 24 hrs after vaccines with temperature to 103.5 & diffuse abd pain with nausea,  All Sx resolved
17JUN pt "felt stiff-legs were stiff; had jerky movement-when arms were pulled back, they had twitching movements"; temp 99.6 A; pt didn't act like normal; trembled; 18JUN92 nurse said it might be a virus; mom feels it was a convulsion;
injection site pain; redness; warmth; This is a spontaneous report from a contactable consumer (patient).  This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Jan2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Feb2021, the patient experienced injection site pain, redness, warmth with outcome of unknown.    Information about lot/batch number has been requested.
No signs, symptoms, adverse events - pt received expired dose of ZOSTAVAX will return 28 days to repeat per Merck recommendations.
Large local reaction, pain and swelling of right arm, lymphadenopathy and fever of 101 degrees, started about 1 hour after injection and lasted 5-6 days.
Nothing too horrible... Nasseau periods, and diarrhea for 2 days, slight headache.  I took some pepto bismol today.  Hope it helps.    I am still not sure if these are due to the vaccine or not?
PSORIASIS BREAKOUT ALL OVER BODY; THREW HIS ENTIRE BODY OUT OF WHACK; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 15-AUG-2021 for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: risankizumab (injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. Age at time of vaccination 49 years old.  No concomitant medications were reported.  On an unspecified date, the patient experienced psoriasis breakout all over body, and threw his entire body out of whack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of risankizumab was not changed. The patient recovered from psoriasis breakout all over body, and threw his entire body out of whack. This report was non-serious.
Injection site swelling, redness, swelling. Fatigue, nausea, lethargic.
Received on Fri at 2/17 a 2:30. No problem. Sat evening started itching & redness at injection site some hardness with irritation. Gave patient Diphenhydramine 25 mg for itching.
C/O soreness at inj site. Surface area red not warm to touch afebrile.
I didn't feel anything the rest of the day, but the next morning I felt that feeling tingling through my arm and it was there every day and wouldn't go away, it was the feeling like when you hit your elbow and it tingles but this was constant. The last few days it's moved up to around the shoulder, and I did have a lump that would come up for a few days but it's gone down.
This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 01-JUN-2009, the patient was administered the zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated by a healthcare providers at the hospital for Bell's palsy and other zoster-related conditions. The outcome of the events was not reported. The reporter considered all events to be related to Zoster Vaccine Live (ZOSTAVAX). Upon internal review, the event of Bell's Palsy was determined to be medically significant.
PATIENT FAINTED AFTER GETTING VACCINE. SHE WAS THE SECOND MEMBER OF HER FAMILY OF 3 GETTING SHOTS  IN THE PHARMACY. SHE WAS CONCIOUS AND ALERT BUT SITTING ON FLOOR AFTER THE RPh WAS ALERTED. REMAINED CONSIOUS AND ALERT WHILE I TOOK HER B/P WHICH WAS 97/87. CALLED 911 AND WAITED WITH PT AND FAMILY UNTIL THEY ARRIVED. SPOKE TO MOM BY PHONE 5PM. SHE WAS DISCHARGED BY PARAMEDICS WITH DIAGNOSIS VASOVAGAL SYNCOPE.
only administered the liquid component to the patient, states the patient only required DTAP-IPV and the HIB was not necessary, with not reported adverse event; Initial information received on 02-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient who experienced only administered the liquid component to the patient, states the patient only required dtap-ipv and the hib was not necessary, with not reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD).  On 02-Jun-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ528AAA (10-Jul-2022)  via intramuscular route in the right thigh for prophylactic vaccination.  On 02-JUN-2022 (latency: Same day) the patient developed a non-serious only administered the liquid component to the patient, states the patient only required dtap-ipv and the hib was not necessary, with not reported adverse event (product preparation issue) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (only administered the liquid component to the patient, states the patient only required DTAP-IPV and the HIB was not necessary, with not reported adverse event).  At time of reporting, the outcome was Unknown for the event only administered the liquid component to the patient, states the patient only required dtap-ipv and the hib was not necessary, with not reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
weakness; fever/chills; fever; headaches; fatigue, tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), CHILLS (fever/chills), PYREXIA (fever), HEADACHE (headaches) and FATIGUE (fatigue, tiredness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M02A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (last year). Concurrent medical conditions included Hypercholesteremia and Hypertension.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced ASTHENIA (weakness), CHILLS (fever/chills), PYREXIA (fever), HEADACHE (headaches) and FATIGUE (fatigue, tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), CHILLS (fever/chills), PYREXIA (fever), HEADACHE (headaches) and FATIGUE (fatigue, tiredness) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) POSITIVE.     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.   patient says that she feels like "she got Covid-19." Reports history of Covid-19 last year. She wants to know how long are these symptoms going to last.
Swollen, tender lymph node; Swollen, tender lymph node; Arm soreness; Fatigue\tiredness; Brief headache; This is a spontaneous report from a contactable consumer (patient herself).  This 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via an unspecified route of administration, at single dose on 18Dec2020 at 09:15 AM for COVID-19 immunisation. Vaccine location was deltoid left. The patient was vaccinated at hospital, age at vaccination 66-year-old. The patient did not have a relevant medical history. Relevant concomitant medications included hypertensive medications and hypothyroid medications. The patient is a therapist that works in the hospital. She stated she has not been overly exposed to Covid. On 18Dec2020, after receiving vaccination, the patient complained of fatigue and brief headache. On 19Dec2020, she felt arm soreness. On 21Dec2020, she noticed swollen lymph node in her neck right by the clavicle, she stated it was tender that there was a couple of teaspoons of fluid surrounding it in that area. She stated it was on the side of the body where she received the vaccination, left deltoid. The patient had recovered from 'fatigue/tiredness' on 19Dec2020, from 'brief headache' on 18Dec2020 and from 'arm soreness' on unknown date in Dec2020. The patient had not recovered from the event 'swollen, tender lymph node'.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020513276 Same reporter, drug and event; different patients
mom states fever don't know how high took to ER recvd shot to bring fever down; prolonged crying 3-4 hrs p/shot; ok next day; pvt MD felt react to DTP;
Information was received from a registered nurse who reported that some patients were administered improperly stored PNEUMOVAX 23 (lot number 1947AA; expiration date unspecified) and RECOMBIVAX HB (MARRS # 1209USA010375). PNEUMOVAX 23 was exposed to two temperature excursions: exposed to 10 degrees celsius for 72 hours and a day later, exposed to 12 degrees celsius for 48 hours. No adverse effects were reported. The specific number of patients was unknown. Additional information has been requested.
4.5 x 6 cm erythema, induration, swelling posterior left arm-anterior to injection site.  No tenderness, no lymphadenopathy.
Arm pain at injection site,  fever,  fatigue.  Affects began about 18 hrs. after receiving the shot and latest about 12 hrs.
got covid after the first dose of the vaccine; got covid after the first dose of the vaccine; This is a spontaneous report from a non-contactable consumer via Pfizer-sponsored program.  A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported the caller has firsthand knowledge. The patient experienced got Covid after the first dose of the vaccine on an unspecified date. The clinical outcome of the event was unknown. Caller inquired if the patient  is eligible to get second dose of vaccine.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Positive Covid 19 Test; Positive Covid 19 Test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), intramuscular, administered in arm left, administration date 16Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administered in arm left, administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Nov2021, outcome "not recovered" and all described as "Positive COVID-19 Test". The patient underwent the following laboratory tests and procedures: Nasal Swab: (18Nov2021) positive, notes: Nasal Swab; PCR: (18Nov2021) positive, notes: PCR. Therapeutic measures were not taken as a result of vaccination failure, COVID-19. Clinical course: It was reported that, patient did not receive any other vaccine in four weeks and no other medications in two weeks. She was not diagnosed with COVID-19, prior to vaccination. She was tested for COVID-19, after the vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Within hours of DT injection was having swelling and erythema at the injection site. 2 days after injection, had 4cm diameter X 1/2cm height area of induration that was warm and tender.
Nausea, vomiting, burping, hiccips, unable to eat, shortness of breath, severe pain to arm.
Large local reaction/ SPV robust take noted, with approx. 5 cm area of erythema, with lymphadenopathy. Treated conservatively with NSAIDs and oral antihistamines, and resolution noted over several days.
fever, shortness of breath, cough, congestion doctor's office visit, then to er-was swabbed for flu, tested positive
Broke out in mild, vesicular rash on 12/30/2004. Seen in Dr office 1/3/05 dx varicella.
Felt achy/ aches; Tired; Injection site hurting; He had a fever above 102F by 24 hours post injection; Chills; His lymph nodes under the arm on the injection side were very raised and swollen.; This is a spontaneous report from a contactable reporter (consumer or other non HCP).  A 12-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in right arm, administration date 19Jan2022 at 19:45 (Lot number: FJ5682) at the age of 12 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing) and "Eczema" (unspecified if ongoing), notes: ezcema. There were no concomitant medications. Past drug history included: Cephalexin, reaction: "Drug allergy", notes: Known allergies: cephalexin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: FA7484; Route of Administration: Intramuscular), administration date: 26Jul2021, when the patient was 12 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: FA7485; Route of Administration: Intramuscular), administration date: 16Aug2021, when the patient was 12 years old, for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 20Jan2022, outcome "recovered" (20Jan2022), described as "Felt achy/ aches"; FATIGUE (non-serious) with onset 20Jan2022, outcome "recovered" (20Jan2022), described as "Tired"; VACCINATION SITE PAIN (non-serious) with onset 20Jan2022, outcome "recovered" (20Jan2022), described as "Injection site hurting"; PYREXIA (non-serious) with onset 20Jan2022, outcome "recovered" (20Jan2022), described as "He had a fever above 102F by 24 hours post injection"; CHILLS (non-serious) with onset 20Jan2022, outcome "recovered" (20Jan2022), described as "Chills"; LYMPHADENOPATHY (non-serious) with onset 20Jan2022, outcome "recovered" (20Jan2022), described as "His lymph nodes under the arm on the injection side were very raised and swollen". The events "Felt achy/ aches", "Tired", "Injection site hurting", "He had a fever above 102F by 24 hours post injection", "Chills" and "His lymph nodes under the arm on the injection side were very raised and swollen." were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, fatigue, vaccination site pain, pyrexia, chills and lymphadenopathy.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. It was reported that although the reporter was aware of the adverse event, it had been waited to report until received a negative PCR Covid test, as the patient's soccer teammates had recently tested positive for Covid. The doctor stated his symptoms were consistent with Covid and she was not certain if there was an adverse event reaction.