chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was not this painful last time; It was not this painful last time; Swollen clavicle and lymph nodes; Swollen clavicle and lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 (Lot number: EL9264) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LOVASTATIN taken for blood cholesterol (ongoing); AMLODIPINE taken for blood pressure measurement (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Lot: EL3248, Exp: Unknown, Administered left upper arm), administration date: 03Feb2021, when the patient was 55 years old, for Covid-19 Immunization. The following information was reported: BONE SWELLING (non-serious), LYMPHADENOPATHY (non-serious) all with onset Feb2021, outcome "recovered" and all described as "Swollen clavicle and lymph nodes"; BONE PAIN (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "It was not this painful last time".  Additional information: The patient had swollen clavicle and lymph nodes after booster dose. The same thing happened after getting the second Pfizer Covid Vaccine, but it's not as severe as this. At end of call, patient commented she was hoping this hurt goes away. It was not this painful last time (after second dose). She still had the knots and swelling like she does now, but not as bad. She mentioned she did not make the report last time until a week or half into it and then it went away.   Follow-up attempts are completed. No further information is expected.
The patient presents with fever, cough, chills x 1 week. Pt reports she started feeling symptoms last week on Thursday and tested positive the next day. She reports she has n/v from the coughing..  The onset was 1  weeks ago.  The course/duration of symptoms is constant.  Location: generalized. The character of symptoms is pain.  The degree at onset was moderate.  The degree at present is moderate.  Risk factors consist of none.  Therapy today: none.  Associated symptoms: nausea, vomiting, cough, fever and chills.
Postmenopausal woman (last menstrual period 11/14/2019) and 17 months later experienced "menstrual bleeding" on 4/28/2021. Two weeks prior to the appearance of bleeding, patient experienced premenstrual symptoms (cramping, breast tenderness).
Covid arm describes it well. Itchy red area around where vaccine was given. Itchy like a mosquito bite. Redish pinkish. A little swollen.
Shooting pains, elevated temperature, joint pain and stiffness. Three vaccination dates 04/30/1999, 06/05/1999 and 07/07/2001.
the patient was a 15 year old male , came in for the first dose of pfizer vaccine, after getting the vaccine , the patient suddenly fainted for a moment, but came back in less than a minute, he was still little dizzy for couple minutes after that, but was perfectly ok after 5 minutes, he also threw up, no other allergic reactions noticed, . mom had mentioned that he hadn't had anything to eat in the morning and he was really nervous too, that might be the reason she said. but we did monitor the patient for over 30 minutes  and he was perfectly fine before he left
Information has been received from a 67 year old female consumer who on "29-DEC-2009 or 30-DEC-2009", was vaccinated with a single dose of PNEUMOVAX 23. The patient stated that "I received PNEUMOVAX 23 in one arm, the specific arm was unspecified, and H1N1 (manufacturer unspecified) vaccine in the other arm either on December 29th, 2009 or December 30th, 2009. Then about 6 hours after vaccination I had severe pain in my arm and I could not move it up, down, or lay on my side. I then had pain in my ribs, diaphragm, achiness all over my body and a headache". The patient called the physician for medical attention. The consumer reported that "the pain was getting a lot less severe but she still was having headaches". No further information is available.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. No concomitant therapies were reported. On 24-FEB-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (10mcg/1mL, 10X1DS/VTF) lot number K003533, expiration date of 07-FEB-2016 (route of administration was not reported), which was stored at -3.333 Celsius Degrees; for 472 hours, -2.222 Celsius Degree for 480 hours and -2.777 Celsius Degree for 168 hours. The type of storage was refrigerator. No adverse effects were reported. No product quality complaint (PQC)was involved. This is one of several cases from the same reporter. Additional information has been requested.
While sitting in high chair, became limp and unresponsive for appproximately 30 seconds. Eyes rolled back in head. No movement of limbs. Seemed normal immediately after.
17 year old female received 2nd dose of COVID vaccine at 1:15pm, at 1:18pm mother alerted pharmacy that patient was not ok.  Patient was sitting in the chair and her limbs went limp and she dropped her water bottle, she was not responding to sound or touch although her eyes were open, laid patient down on the floor with feet up and she immediately regained consciousness and was able to talk. She stated that she lost vision and was ok. Mother panicked and called 911, ambulance arrived at 1:20 and escorted the patient to the ambulance to gather more information.
No additional adverse event.; administered a dose that had been improperly stored; This spontaneous report was received from a medical assistant and refers to a 9-day-old male patient. There was no information about his concurrent conditions, concomitant therapies or medical history provided. On 10-JUL-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, orally, lot # 1660944, expiration date 16-APR-2021 (strength and dose were not reported) for prophylaxis.  On an unknown date, the dose of the vaccine was exposed to temperature excursion at 0.5 Celsius degree (C) for 1 hour 49 minutes. There was no previous temperature excursion. The call was due to digital data logger. No additional adverse effect was reported.
Patient came to the office late this afternoon because of the onset of rigors and feeling ill.  Due to her situation, we saw her right away.  By history, she was feeling perhaps a little under the weather yesterday in a nonspecific way.  She got up feeling well this morning, and remembers having her influenza vaccine at about 10:30, this morning.  She felt fine afterwards and had a massage done for neck discomfort between 2:00 and 3:00.  It was about 3:00 in the afternoon that she started having rigors.  She comes in to the office shaking and covering herself up with a jacket.  She was not aware that she is febrile, but is.  On reviewing her medications, she takes nothing by prescription, but is on a number of herbs and vitamins.  I questioned her in detail regarding this illness as there is no obvious explanation for the rigors.  She denies headache or dizziness, sinus symptoms, or sore throat.  There has been no nausea or vomiting, abdominal pain and no diarrhea or change in bowel habits.  She has absolutely no cough, shortness of breath, chest pain, or myalgias at this point.  She denies any urinary symptoms.  There has been no rash.  She has had a flu shot every year without problem.  There has been no itch or urticaria with this flu shot.  She has had a history of smoking, goiter, and from a surgical standpoint is that only a fine needle aspiration of the thyroid and carpal tunnel release.  Blood pressure 110/68.  Heart rate 80 and regular.  Temperature 102.2, which I checked several times.  O2 saturation is 99%.  On exam, she is shivering and has rigors.  She is alert and otherwise looks well.  She feels warm.  On ENT examination, there is no adenopathy.  Her ears are normal.  Pharynx is clear.  No erythema.  Lungs, clear.  Good breath sounds anteriorly and posteriorly.  Heart exam normal.  No murmur.  Abdomen - soft and nontender.  There is no hepatosplenomegaly.  No tenderness anywhere.  No hernia.  Extremities - normal.  No edema.  Skin - no rash.  From the lab standpoint, we checked a urinalysis, which was clear and a white count, which was 9000.  I stayed with her for about 45 minutes through this evaluation.  By then end of the period of time, the rigors had stopped and her fever had peaked up to 102.2.  Again, on re-reviewing the history, there is no symptom that directs us in any area.  Theoretically, this could be a flu shot reaction or reaction to massage, less likely.  More than likely, this is a viral syndrome.  I impressed on her the need to let us know if things change or worsen.  I will call her tonight and we will have someone call her tomorrow morning.  She knows to call us when or if needed.  Presently, there is nothing to use an antibiotic for and I think we need to simply follow.  She is well aware of this and agrees.  Case is closed on 10/23/07 at 9:10 pm.
Case number PHEH2014US014974 is an initial spontaneous report received from a nurse on 25 Jul 2014. This report refers to 22 year old female patient. Her past medical history and concomitant medications were not reported. The patient received the Men A lyophilized powder component of MENVEO (batch number: A14031) intramuscularly which was reconstituted with sterile diluent instead of Men CWY liquid conjugate compound on 25 Jul 2014. No adverse events were reported following this medication error (wrong solution used in drug reconstitution).
accidentally received 2 doses of FLUZONE HD QIV with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 85 years old female patient who accidentally received 2 doses of Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rsv Vaccine (Rsv Vaccine) for Immunisation.  On 14-Oct-2023, the patient received a dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine and on 16-Oct-2023 she also received another dose of the same vaccine (form, strength: unknown) (lot number, expiry date: not reported) via unknown route in unknown administration site for immunization.   On 16-OCT-2023 the patient accidentally received 2 doses of Influenza Quadrival A-B High Dose Hv Vaccine, with no reported adverse event (extra dose administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was unknown for the 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.
MODERN 0.5 ML FOR IM LOT 015M20A EPX:07/29/2021 No known adverse events.
SINCE HAVING THE SHOT I HAVE BEEN GETTING HEADACHES 2-3 TIMES A WEEK AND I USED TO MAYBE GET A HEADACHE ONCE A YEAR
Fatigue; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 75-year-old patient of unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) at the age of 75-years, via intramuscular in left arm on 09Feb2021 13:30 at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. The patient experienced fatigue on 10Feb2021. Outcome of the event was unknown. Patient received second single dose of BNT162B2 (lot number: EN6208) via intramuscular in left arm on 11Mar2021 for COVID-19 immunization.   No follow-up attempts are needed. No further information expected.
Woke up 11 days after TDaP vaccine with acute symmetrical arthritis in jaw, shoulders, hips, hands, feet, then moved into neck after 2 months. Taking Prednisone and pain medication, but after 2 months, prednisone lost its effectiveness at 10mg, upped dose to 12.5mg, but not working. Have Dr. Appt this week again with rheumatologist.
Sore arm; rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE RASH (rash) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE RASH (rash). At the time of the report, VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI - TCR
BP 202/102; BP 185/106; BP 179/94; BP 199/113; This is a spontaneous report from a non-contactable pharmacist. A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6199), intramuscularly in the left arm on 04Mar2021 (at the age of 39-years-old) as a single dose for COVID-19 immunization. The patient's medical history included COVID-19 on an unspecified date. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6199), intramuscularly in the left arm on 10Feb2021 (at the age of 39-years-old) as a single dose for COVID-19 immunization and experienced cardiac and febrile symptoms including chest pain/discomfort, insomnia. The patient consented to receiving the second dose after education with RN, physician Dr. (Name), and pharmacist. The following tests were reported for 04Mar2021: at 1535: BP (blood pressure) 202/102, HR (heart rate) 91, O2 100%, Temp 36.8C; at 1540 BP 185/106, HR 98, O2 100%, Temp 36.8C; at 1545 BP 179/94, HR 90, O2 100%; at 1557 BP 199/113, HR 88, O2 100%, Temp 36.2C. The patient received no medications in the emergency department. The outcome of the event was unknown. It was also reported that the patient was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event cannot be 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 RAs, Ethics Committees, and Investigators, as appropriate.
pt recv vax on 6NOV95 & devel acute chicken pox 11FEB97;
Patient has a 10cm red circular raised area on right thigh - cellulitis of right leg - placed on BACTRIM antibiotics.
I received the second dose on Tuesday and on Thursday morning I woke with 2 lesions that were painful on my left side of my tongue and a maculopapular rash on bilateral legs, chest and left arm. By Friday the lesions on the tongue were mostly resolved and the rash on my body was beginning to clear - it was less red and there were fewer lesions. However, Friday late afternoon I began to notice pain and burning just above my gluteal fold on the right buttock and was able to see a crescent shaped lesion that was very red, raised and extremely painful in a burning way.  This was first seen in spite of discomfort a couple of hours earlier (I was at work) around 6:30 PM. By 10:00 PM I began to notice the same burning sensation very suddenly and in the same location on the right buttock and was able to find another lesion identical to the first on that side.
Sunday night after going to bed or maybe even before I had sinus drainage with a sore throat, in the morning I gargled with salt water and began my day, later I had sinus pressure and a headache so I had my husband go to the store and get me CLARITIN 24 hour. The next day I got MUCINEX D and took this and I had begun coughing on Tuesday December sixth. On Wednesday December the seventh I took a COVID-19 antigen test that was positive the same test had taken on Monday December fifth that was negative.
electrical tingling feeling in the arm; dizziness; severe heart palpitations; fatigue; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (electrical tingling feeling in the arm), DIZZINESS (dizziness), PALPITATIONS (severe heart palpitations), FATIGUE (fatigue) and HEADACHE (Severe headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE and VALSARTAN for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 20-Feb-2021, the patient experienced VACCINATION SITE PARAESTHESIA (electrical tingling feeling in the arm), DIZZINESS (dizziness), PALPITATIONS (severe heart palpitations), FATIGUE (fatigue) and HEADACHE (Severe headache). At the time of the report, VACCINATION SITE PARAESTHESIA (electrical tingling feeling in the arm), DIZZINESS (dizziness), PALPITATIONS (severe heart palpitations), FATIGUE (fatigue) and HEADACHE (Severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant treatment information provided
9 x 9.5 cm redness and felt harder and warmer than surrounding area appear 48 hours after being vaccinated.
chills overnight; FEVER; SWEATY; This is a spontaneous report from a received from Pfizer program. A contactable nurse reported that patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chills overnight, fever, sweaty. Outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Experiencing hearing loss in both ears day after 2nd Booster of Pfizer-BioN Tech
PNEUMOVAX given 12/3/09. Developed pain injection site 2 days later. Unable to raise (R) arm above 90 degrees. Treated with NSAIDS until started on physical therapy end Jan. By Feb 16 visit feeling much better & ROM back to normal mostly except for slight tenderness.
Tired; Dizzy; unstable; shoulder/injection site pain; shoulder/injection site pain; Arm pain; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 15Jan2021 (at the age of 83-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shoulder/injection site pain and arm pain in Jan2021 and tired, dizzy, and unstable on 16Jan2021. The clinical course was reported as follows: The patient initially experienced shoulder/injection site pain and arm pain. On the next day after vaccination, she felt tired, dizzy and unstable. The day after was much better and on the fourth day after vaccination, she was back to normal. The clinical outcome of shoulder/injection site pain, arm pain, tired, dizzy, and unstable was recovered on 18Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This report has been received from the nurse reported that VARIVAX (Merck) (lot# H020587, expiration date 13-NOV-2014) and PROQUAD (Merck) (MARRS# 1311USA012185) were trough unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 26-SEP-2013 the patient (age and gender not reported) was administered the unsupported VARIVAX (Merck) (dose and route not reported). No adverse effects reported. This is one of several reports received from the same source (MARRS# 1311USA002616, 1312USA003307, 1312USA003308, 1312USA003309, 1312USA003306, 1312USA003310, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003311, 1312USA003317, 1312USA003399, 1312USA003400, 1312USA003401).
passed out/stared to black out; got really hot; had trouble breathing; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0158), via an unspecified route of administration, administered in Arm Left on 08Apr2021 13:00 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 30 years). Medical history included anxiety, depression. Concomitant medications included trazodone; phentermine (ADIPEX [PHENTERMINE]); omeprazole; citalopram; alprazolam (XANAX). The patient previously took Imitrex and experienced allergies. On 08Apr2020 (13:00), the patient stated that she felt fine and was texting. Then all of a sudden she got really hot, had trouble breathing, and stared to black out. She was blacking out. She could hear someone asking if she was okay and if she needed help. She dropped all her things and passed out. The patient was not pregnant. The patient did not received any treatment for the events. Outcome of the events was recovered on an unspecified date.
Received vaccination and it began to swell from inject site to elbow.  Received tylenol and cold pack. Became nauseated later.  Next day warm compress applied.  Limited motion and soreness remains today.
Information has been received from a 25 year old female consumer with no medical history or allergies, who in approximately February 2005 "six months ago", was vaccinated with a dose of hepatitis A virus vaccine inactivated (lot# 648459/0856P). Concomitant therapy included typhoid vaccine (unspecified), poliovirus vaccine and Chloroquine. After receiving hepatitis A virus vaccine inactivated, the consumer only had one period. It was noted that she did not have one for four months so she began taking birth control pills to see if that would help. She reported that she had one period then, so she stopped taking the pills, and she has had none since. Unspecified medical attention was sought. Laboratory diagnostic tests included blood work. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Developed pruritic hives on buttocks, thighs, and arms, with bilateral hand swelling over 72 hours after vaccine administration. Hives resolved with Benadryl administration.   Had temperature of 99/100F and myalgias for 48 hours after vaccine administration which resolved prior to onset of hives.