chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; fast heart rate; dizziness; pain; headache; tiredness; feeling unwell; This is a spontaneous report from a contactable consumer (son) that. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 25Feb2021 10:30 (Batch/Lot Number: Lot EN5318) as DOSE 2 SINGLE for covid-19 immunization. The patient past Medical history included, deafness from an unknown date and unknown if ongoing His Deafness was diagnosed at birth, tooth impacted from an unknown date and unknown if ongoing Treatment drug:  Amoxicillin 875mg, Motrin and Tylenol 3 with codeine.  The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. Caller states that she is calling on the phone on behalf of her son (Name-withheld). She is calling about the Pfizer BioNtech covid vaccine. Her son had the second covid shot and he woke up this morning with a fever of 101, fast heart rate, dizziness, feeling unwell, nausea, pain headache and tiredness On 26Feb2021. Caller states that they are now up at "(withheld)" to be treated. Caller states that she has notified Pfizer of all about side effects, and she needs to know what to do next. Caller was informed that Pfizer could not provide and specific medical treatment or medical advice.  All symptoms started this morning at 8:30AM, he woke up feeling this way. When queried for a physician, caller states that she doesn't know yet because they are at the urgent care and he hasn't been seen yet, she doesn't understand why since his fever is 101 and they are still waiting. She just knows the practice called "(withheld). While caller is on the phone with this call handler, she states that a nurse has taken her son back for his weight and temperature, they are also going to get some blood. Fever: They just checked, and his fever now is 99.7F, it has come down. Caller clarifies that she used a manual temperature at home.  Heart Rate: it is 130 now. Caller states that she does not know what his heart rate was at home. Dizziness: It is not on the list of things, but when he got moving around to get ready to come out, he was ready to throw up. His equilibrium is off because of the deafness, so it doesn't take much to get him off kilter. Nausea: is the same and Headache is worse, he also woke up and had the shakes. The patient underwent lab tests and procedures which included blood test: unknown result on Unspecified date , body temperature: 101 and 99.7 on Unspecified date and heart rate: 130 result on Unspecified date.The event outcome was Recovering for fever and Not recovered for rest of the events.  No follow up attempts are possible. No further information is expected.
Pt. developed hives several days after receiving PNEUMOVAX. No other symptoms some redness and swelling of injection site (severity not documented). Resolved in approx 10 days.
Vaccine was given on 11/9/2017. She had no soreness or reaction at site until 11/12/2017. The late reaction consisted of a small hard nodule under the injection site that was not visible but it was palpable. She also complained of tenderness at the site. She took Ibuprofen for the discomfort. She reports it was warm to touch on 11/12, but on 11/14/2017 when it was assessed at the health unit it was not warm to touch. She used warm compresses and it improved with decreased soreness and size. Almost gone at this date of 11/20/2017.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report was received on 28 July 2008 from another manufacturer who received the report from a consumer.  A female patient (age and date of birth not reported) had received an Influenza vaccination six to eight years ago (manufacturer, lot number, route and site of injection not reported), and an unspecified amount of time later she developed "a horrible case of pneumonia and almost died".  She was prescribed prednisone and her feet "swelled up".  No further information was provided at the time of the report.
C/O pain at injection site with difficulty bending arm at the elbow (progressive pain post injection). Also displayed corporal spasm-type positioning of fingers and hand. Given IV Solu-Cortef, IV Pepcid, and PO Parafon Forte and Flexeril during hospitalization. Medical record on 04/28/04 states: fever, soreness, neuromuscular dysfunction, joint stiffness, immunization reaction.
My pharmacy manager spoke with the patient over the phone to remind the patient that he is due for his second dose of SHINGRIX. He stated he will not be receiving the second dose due to an adverse event. He stated he went to the hospital the next day from a possible stroke. His primary care physician suspected the vaccine may have been the reason for the stroke as it could have possibly hit a nerve. The patient nor the doctor's office contacted us in regards to the possible side effect of the vaccine.
Presented with SOB, hypoxia; + Covid in ED; admitted to HCF with Covid PNA; tx with steroids, remdesivir, zinc
Vaccination site on arm is swollen, red and painful. A knot has formed about the size of a golf ball.
Light headedness; nausea; This is a spontaneous report received from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 02Mar2021 11:00 in left arm (Lot number EN6203), at the age of 32-years-old, as a single dose (dose number unknown) for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Mar2021 at 15:00, the patient experienced light headedness and nausea which set in about 4hours after the vaccine was administered and lasted for around 3-4hours before going away. Patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of light headedness and nausea was recovered on 02Mar2021 at the time of report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: vaccination administration time (11:00 am), stop date of events (02Mar2021) and vaccination facility information were added.
Client age 69 was given a Moderna 0.5ml Pediatric 6 months - 5 years dose instead of a Bivalent dose. Client was observed for 25 minutes after administration with no reactions.
Immediate lightheaded effect after injection. Illness begins the night after vaccination (uncontrolled vomiting/heaving, fever, profuse sweating, headache, dizziness, fatigue) lasting 3 days. General malaise and prominent fatigue continue after cessation of initial violent symptoms and continue currently. This initial reaction was followed by 2 months of extreme depression, brain fog, decrease in memory, and general fatigue, so much that my quality of life has been affected. Appointment scheduled with Dr. in ~April to investigate my continuing symptoms. Episodes of presyncope begin in May. An ekg is preformed in May by Dr. showing tachyarrhythmia with short PR syndrome. This is the first abnormal ekg I have received and I have never had heart problems previously. Referred to Dr. who confirmed inappropriate sinus node activity resulting in short PR tachycardia via monitoring using a 2 week heart monitor. Average heart rate at rest is about ~130 bpm with swings between 70 bpm and 190bpm. Prescribed Corlanor to decrease heart rate.
Two weeks after 2nd Covid shot (3/17), a couple of blemishes appeared on rt. cheek of face. Started to experience intense pain in lower jaw. Saw the dentist on 3/18 to rule out a tooth issue. Dentist found a small crack in lower molar & crowned it that day. He felt that was the issue. The following day, more blemishes/blisters appeared on cheek & face. More pain was experienced radiating from ear, across cheek & in the mouth. Saw the Dr. on 3/19 & was diagnosed with Shingles. Prescribed Valacyclovir HCL & Prednisone. Now (3/21), the blisters are prevalent on my eary, running across the cheek, chin, lower lip, tongue & gums. Pain is intense -stabbing, tingling & itching.
Vaginal discharge, feel shaky (gotten progressively worse), increased heart rate (gotten progressively worse), chest discomfort, increased anxiety
Information has been received from a registered nurse concerning a 57 year old patient who on 04-MAY-2009 inadvertently received ZOSTAVAX (Merck) instead of VARIVAX (Merck) (MSD). No symptoms reported. Additional information has been requested.
I woke up with cold chills. Throughout the day I had fatigue in all extremities, irritability and sensitivities to the skin on my arms. I felt discomfort while urinating throughout the day. I had a low grade fever later in the day.
Tongue swelling, dizziness, brain fog, fainting.   Lasted 3 hours.
I had severe joint pain, rash, and mild fever all over my body. I went to the doctor and she thought it was lupus related but could not confirm if it was the shot or lupus. The joint pain, rash, and mild fever lasted for 48 hours after my 2nd dose.
temperature excursion; Dose/Frequency: 0.5 ml of ROTATEQ; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history and drug allergies and reactions were not reported.      On 14-DEC-2020, the patient was vaccinated with the temperate excursion vaccines of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was not provided; lot# was S040483 and expiration date was 19-JUN-2021) 0.5 ml orally and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength and route were not provided; lot# was T001206 and expiration date was 03-JUN-2022) 0.5 ml for prophylaxis.      This is one of three cases from the same reporter.; Sender's Comments:  US-009507513-2012USA007474: US-009507513-2012USA007679:
Pt returned to office 3/6/08 with rash of about 24 hrs. Spreading and noted scratching. History of fever 101 and vomiting 2 days earlier. Examining MD noted vesicles with erythemic rash - generalized; Diagnosis clinically of Varicella. Treatments recommended: Benadryl, Tylenol and/or calamine lotion as needed.
She's in the hospital and can't talk much, she has pneumonia and breathing issues. They are not sure how the virus was contracted. PUI had no appetitie and didn't eat for 3 days. They thought at first that she had sinus infection. PUI is on steroids and antibiotics. She was nauseated but never vomited. She had a heart attack years ago and has had bladder cancer.
p/vax pt devel a h/a;pt devel a fever on T100;pt devel a rash on face & torso;pt devel a macular rash scattered & back & joint aches;
Patient became inconsolable and would not nurse. Event lasted approx. 2 hrs. Gave 1.25 ml infants TYLENOL in office.
10 or so days after booster shot I started developing hives that move to different locations on the body throughout the day, concentrated on the neck and back but also on face, scalp, midriff, and arms. At urgent care I was proscribed prednisone and started that today, it seems to have started helping slightly. I have never had a reaction like this to anything in my life. The doc noted I was the third person that day to have been boosted on dec 23rd that came in with similar rash symptoms.
DTAP inj site red & swollen 25-50cent size concern r/t hard, red, circular swollen area down from inj site;ice & motrin no effect;27JUN saw MD @ after hours clinic-tx w/ATB effective;
She felt light headed, general sense of being "unwell", nausea.  We had her rest about 20-25 minutes.
Chills approximately 12 hours after vaccine, nausea after approximately 20 hours of vaccine. Body aches, extremely weak, fatigued, and high fever over 102 approximately 22 hours after vaccine.
Patient had shoulder surgery in right arm a few months ago, requested that we give the vaccine in his right shoulder, where his surgery had been. Developed pain in the deltoid and surgery following the vaccine and went to the ER 2 days later, where he received a steroid shot.
patient was administered PENTACEL and also had IPV vaccine instead of pneumococcal vaccine with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient of unknown age and gender who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and also had poliomyelitis vaccine (inactivated) vaccine instead of pneumococcal vaccine with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] (Suspension for injection) (strength, lot number; expiry date not reported) and an unknown dose of suspect poliomyelitis vaccine (inactivated) produced by unknown manufacturer (strength, formulation; lot number; expiry date not reported) via unknown route in unknown administration site for Immunization. Information regarding batch number was requested in the case.  On an unknown date the patient was administered pentacel and also had IPV vaccine instead of pneumococcal vaccine with no reported adverse event (wrong product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   Nurse declined to provide additional information  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.
I cannot move my arm. I was up most of the night and I still have very limited arm movement. It is even very difficult to complete this form.
swelling of injection site, nausea and vomiting, chills, muscle aches, headache. side effects beginning late night after the vaccine, muscle aches and chills continued for about 24 hours There were no side effects after the first dose covid vaccine
Client received vaccine. Client states she has a history of fainting. Client was moved to anti-gravity chair before vaccine. After vaccine, about five minutes after 1243 Client reported feeling ?sweating? and ?hot?. Client stated this was a normal whenever she gets a shot Client was offered a cool pack,. Client was AAOx3 and client stated she was feeling numbness and tingling, Headache, and dizzy. Vitals signs at 1243 BP 132/86 HR 86 02 99%. Client states she did eat before vaccine and had water. Client had no shortness of breath, no difficulty breathing, no itchiness in any part of her body, no redness on face, neck or arms observed by RN. Water was given and client was able to drink water. Vitals at 1252 BP 124/79 HR 82 RR 14 02 97%. Client stated she could see like ?floaties? in her eyes, ?blurry vison? and legs tingling. At 1255 Client stated ?tingling is going away?. 1258 BP 120/72 HR 79 RR 14 02 99%. 1258 Client stated tingling was slightly better. At 1307 Client stated blurriness is less and there?s only tingling waist down. At 1308 Client sat up in chair and placed feet on ground. At 1309 snack was given, which client ate. At 1311 RN checked pupils, they were equal and reactive bilaterally. Vitals 1311 BP 150/89 HR 86 RR 14 02 99%. At 1313 Client stated ?sitting down helped, it?s going away? 1316 Vitals BP 124/82 HR 83 02 99% RR 16. At 1317 client stated, ?blurriness is gone?. Client was offered EMS for further assessment client declined. Client was recommended to follow up with her PCP in 24 hrs by RN , also recommended ER precautions if symptoms worsen or in case of any life-threatening symptom. Vsafe website was provided for client. Client was accompanied by her ex-husband and was going to drive her home. At 1320 Client left vaccination site in a steady gait
pt recv 4th dose of vax & 2 days p/vax pt exp a facial herpetic lesion on nose;
Adult received Engerix-B pediatric (0.5 ml); Adult received Engerix-B pediatric (0.5 ml); This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 62-year-old male patient who received HBV (Engerix B pediatric) (batch number CM294, expiry date 19th April 2024) for prophylaxis.   On 16th September 2022, the patient received the 2nd dose of Engerix B pediatric .5 ml. On 16th September 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 16-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received pediatric dose of Engerix B which led to underdose and adult use of a child.
Rash on torso and abdomen. Spread to arms and thighs. Very itchy
This spontaneous report was received from a Certified Medical Assistant referring to 10 unspecified patients of unknown age and gender. The patients medical histories and concurrent conditions were not reported. On an unknown dates, the patient were vaccinated with improperly stored doses (Temperature 75F, between a time frame of 5 days) of oral, ROTATEQ, (Lot# L013206; expiration date 29-JAN-2017). Concomitant medications was not reported. No adverse effects reported. Additional information has been requested.
Pt received primary series of Lymerix on 3/2/00, 4/4/00 and 5/1/00 with adverse reaction. She received booster on 4/26/01 and developed polyarthralgia/arthritis with intermittent fever (generally 99F-100F but as high as 103.5F on 1 day) starting in mid June, 2001. I have not seen her since vaccination. Got information by phone. Ongoing symptoms. Not responding to Motrin or glucosamine. I do not have copies of lab data or medical records re this reaction; am depending on information provided by pt by (phone).
Breakthrough case admission after 3 vaccines  Moderna 4/17/21 Lot# 047A21A;  MOderna 5/8/21 Lot# 043B21A;  MOderna 12/3/21 Lot# 033F21A
Loss my hearing in left ear; Light ringing/buzzing in right ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Loss my hearing in left ear) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DEAFNESS UNILATERAL (Loss my hearing in left ear) (seriousness criterion medically significant) and TINNITUS (Light ringing/buzzing in right ear). At the time of the report, DEAFNESS UNILATERAL (Loss my hearing in left ear) and TINNITUS (Light ringing/buzzing in right ear) had not resolved.        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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-118211 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Child was unable to walk on right leg.  Area of redness and swelling about the size of a quarter. This resolved after 48 hrs.
Information has been received from a Nurse Practitioner (N.P.) concerning a 62 year old female who on 03-APR-2009 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck). The patient had "redness, warmth, and induration at the injection site after the vaccine". It was reported the patient "also had a low grade fever of 99.0 F and was started an antibiotic". The patient sought medical attention and was seen by nurse practitioner. The patient was recovering. Additional information has been requested.
This spontaneous report was received from a physician, referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions, drug and allergy history were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot number M036292, expiration date 17-AUG-2018 and lot number M041079, expiration date 06-OCT-2018 (dose, frequency and administration route were not reported), for prophylaxis.  Concomitant therapies included a properly stored sterile diluent used for reconstitution (lot number and expiration date were not provided). The data logger registered a temperature of 8.8 Fahrenheit (F) for 8 months. There was not previous temperature excursion. No adverse effects were reported.
This spontaneous report as received from a medical assistant reports that some unspecified patients on an unspecified date may have received a pediatric dose of 0.5ml VAQTA (lot number H010437, expiration date 28-FEB-2015; H010187, 28-FEB-2015) (dose, frequency and route not reported) that from 22-MAR-2013 to 26-MAR-2013 some vials of VAQTA had been exposed to 0 degrees Celsius for 96 hours and had developed a filmlike coating inside the vial. The medical assistant reported that some vials were clear, with cloudy sediment that resuspends, and that others were essentially clear, with the same resuspending sediment, but also appeared to be coated with a film-like substance. The solution was reported to be clear, and maybe thinner than expected. No adverse effects reported. A product quality complaint has been filed for appearance change of vaccine. This case is linked to MARRS # 1303USA013510, 1304USA000421, 1304USA000422. Additional information has been requested.
Vaccination failure; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EP7533), in right arm and on 01May2021 as dose 2, single (Lot number: ER8736) at the age of 47 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Nov2021 as dose 3 (booster), single (Lot number: 037F21A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL, start date: 26May2022, stop date: 08Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Indication: Covid-19 immunization; (04Jun2022) Negative; (08Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.