chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of nodule injection site in an unknown number of subjects of unspecified age and gender who was vaccinated with PEDIARIX (GlaxoSmithKline). On unspecified dates the subjects received a dose of PEDIARIX (unknown volume and route, unknown thigh). At an unspecified time after vaccination with PEDIARIX, the subjects experienced nodule injection site ("knots in leg'). The nurse reported "multiple" subjects with "knots on their legs where the PEDIARIX injection was given." The nurse reported that the office gave the subjects "more than one vaccine injection in the same leg" but these vaccines were not known at the time of reporting. At the time of reporting the outcome of the event was unknown. The nurse reported that the "knots were still there" when the subjects returned to receive their next dose of PEDIARIX. Follow up received from nurse on 19 March 2013. The nurse stated that "all infants with whom they administer PEDIARIX to, are getting knots in their legs where PEDIARIX was administered." The nurse stated that PEDIARIX is the only vaccine administered into "their one thigh." The nurse also stated "they do not administer any other vaccines to these infants in the same thigh as PEDIARIX." Per the nurse, the knots were "still there 2 months later when the patient comes back for their next dose." On unspecified dates the subjects received a dose of PEDIARIX (unknown details, unknown thigh) and on unspecified dates the subjects received a dose of PENTACEL (unknown details, unknown thigh) and experienced interchange of vaccine products. The nurse stated that the office "switched the patients over the PENTACEL and administer PENTACEL instead of PEDIARIX." The reporter stated that when the subjects "get the PENTACEL injection, their patients do not get knots in their thighs like they do when they receive PEDIARIX." The office again switched back to using PEDIARIX, and "as soon as they went back to giving their patients PEDIARIX, the patients again experienced knots in their legs." The nurse stated that their office will no longer be using PEDIARIX. No further information was provided. Follow-up information was received on 03 May 2013 via healthcare professional who provided details on one subject who received PEDIARIX in the left thigh. The onset of events occurred on 01 March 2013 when the subject was approximately 6-months old. Treatment action taken with PEDIARIX included warm compression and massage. The series with PEDIARIX was not discontinued or delayed. The subject experienced adverse events with previous vaccinations; when the subject was 2-months old in approximately October 2012, PEDIARIX was administered and they experienced "little swelling and redness". The healthcare professional did not consider the events serious. The events were not attributed to medical history/concurrent illness, lack of efficacy, erroneous administration or transmission of infectious agent or medicinal product. An update outcome of the events was not provided.
Patient received injection on 11-1-02 after injection had severe pain, swelling and redness. At 12:29pm on 11-2-02 went to ER received IV Timentin, Salumedrol IV, Epinephrine SQ and Bendryl 50 mg IM. Patient also had reaction to Timentin(hives & itch) was discharged at 6:20pm from ER and follow up with ER on 11-3-02 and again on 11-4-02 at primary care physician office.
Flu-like symptoms: temperature 101.5 from 11/06 1:00PM to 11/08 3:00AM; lethargy; general malaise, flushed cheeks, chills, complained of dizziness, some coughing. She has mostly recovered at this time, but congestion remains.
Localized pain and swelling that worsened at 48 hours, low-grade fever, chills, tenderness, heat and erythema. On day 3, 8" X 6' area but erythema and heat decreasing. This was the 4th dose.
Began having diarrhea @ 6:30am,got a sore throat & coughing around 3pm. By 5:30pm Had fever with chills. Was in bed with flu like symptoms for 48 hrs.
Site of injection is a bump that is probably as big as a golf ball, it?s red, swollen, itchy, warm at touch. Unsure if my skin is red due to having a rash from the vaccine.
Narrative: COVID infection following COVID vaccine series 01/26, Moderna , dose #1 02/23, Moderna , dose #2 08/27 pt cc: diarrhea, headache, rhinorrhea exposure: unknown 08/31 COVID swab, result: detected 08/31 SARS-COV-2 LINEAGE B.1.617.2 08/31 SARS-COV-2 CLADE 21J DELTA
Site: Pain at Injection Site-Severe, Systemic: Fever-Medium, Additional Details: Patient taking Ibuprofen for fever and pain
One day shy of two weeks post had an ocular migraine; This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMIC MIGRAINE (One day shy of two weeks post had an ocular migraine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OPHTHALMIC MIGRAINE (One day shy of two weeks post had an ocular migraine). At the time of the report, OPHTHALMIC MIGRAINE (One day shy of two weeks post had an ocular migraine) outcome was unknown.            No relevant concomitant medications were reported. Patient had the migraine weekly since its occurrence. No treatment information was provided.  Company comment: Very limited information regarding this event has been provided at this time. The event may probably be related to the patient's comorbidity, additional information required.; Sender's Comments: Very limited information regarding this event has been provided at this time. The event may probably be related to the patient's comorbidity, additional information required.
Headache, Fever, Arm pain, severe neck and wrisk and body ache, Fever 103 Narrative:
4/25/12 (1226) Pneumococcal vaccine 25mcg/5ml. 4/26/12 (0530) Body aches, (L) arm swelling at site, worsening body aches - legs, hips, back, chest. (0900) Fever 105 degrees F. Rx -IV steroid taper see dc summary. 4/27 DC home. The patient was admitted to the hospital the afternoon of April 24 with a significant migraine-type headache. This is a fairly routine admission for this patient. We have seen her quite a bit for migraine headaches. She was actually pretty much improved and getting ready to go home when it was noted that she did not have her complete set of pneumococcal vaccination. She received a pneumococcal vaccination on 04/25/2012 at 12:26 in the afternoon. She was ready to go home the following day when she woke up early in the morning around 5:30 with body aches, left arm swelling at the site, worsening body aches. She complained of leg pain, hip pain, back pain and chest pain. Chest pain was really chest wall pain. At 9 o'clock in the morning on the 26th, she spiked a fever to 105 and was miserable. She had a set of laboratories. Laboratories done at that time: CMP, CPK, UA all of which were normal. She was started on a steroid taper of DECADRON 4 mg IV q.6 hours for 2 days and then she will continue on her wean at home. She will do 4 mg q.8 hours for 2 days and then q.12 hours for 2 days and then q. 24 hours for 2 days. In addition, she will be started on the SINGULAIR 4 mg p.o. daily. During the time when she was having her reaction, she was started on IV fluids at 120 mL per hour and PEPCID 20 mg IV q.12 hours. This morning, she seems to be doing well. Her migraine is very low grade. She is sitting up in bed watching TV. Her left arm is still swollen and tender. She has been using ice as needed for the pain. It clearly responds to the steroids and in discussion with mom and the patient, they have decided they wanted to go home today, that she can continue to rest at home. A VAERS report has been filed with her reaction to the pneumococcal vaccine. Her most recent vaccine as MENACTRA which was given on 04/06/2012 also in the left arm.
Rapid eye movement like "having a mini-seizure"; Fainted; Feeling warm; A spontaneous report (United States) was received from a pharmacist concerning a 21-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fainted and experienced to have rapid eye movement like "having a mini-seizure" and feeling of warmth.  The patient's medical history included historical seizures. Concomitant product use was not provided by the reporter.   On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number:026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 02 Feb 2021, a few minutes after the injection, the patient fainted then recovered but again fainted and was noted to have rapid eye movement like "having a mini-seizure". HCP managed her with ice pack as patient complained of feeling warm and she recovered in less than 30 minutes.  Treatment information was not provided.    The outcome for events fainted, rapid eye movement like "having a mini-seizure"" and feeling warm were resolved.; Reporter's Comments: This spontaneous report concerns a 21-year-old, female patient with historical seizures. who received experienced the patient fainted then recovered but again fainted and was noted to have rapid eye movement like "having a mini-seizure." The event occurred a few minutes after the administration of mRNA-1273 vaccine (Batch number: 026L20A, expiration date: unknown).   Treatment administered include Icepack and outcome is resolved.  Based on the information provided which includes a strong temporal onset between the vaccine administration and the event, a causal association cannot be excluded. However, event is confounded by the subject's history of seizures. Feeling warm is consistent with the safety profile of the product.
5:59 pm c/o "slight" lightheadedness.  denies dizziness blurred vision.  Skin W/D
Patient said she woke up on 4/21/18 at around 1 am with arthritic symptoms that seemed to have suddenly become worse and could barely move or walk. She experienced extreme myalgia and severe inflammation of joints. She also had redness at site of injection. She almost went to the emergency room but decided to wait till the morning. She then said as morning came, the symptoms got less severe and she went for some simple shopping to grocery store. The symptoms were significantly less by morning of 4/22/18 and she was better by afternoon of 4/22/18. She wants her experience reported to the makers of the vaccine.
Fever, chills, nausea, headache.  plus frequent urination.  thought I had UTI -didn't.  Because of Covid I had a covid test which came back negative
Stuffed nose; Joint soreness on various parts of body; Muscle soreness on various parts of body; Fatigue; Metallic taste and smell; Metallic taste and smell; Loss of appetite; Nite sweats; Hot flashes; Minor headache; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 14Apr2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included anemia. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid (VITAMIN C), iron (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), sambucus nigra fruit (ELDERBERRY) and probiotics (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 23Mar2021 at 18:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 22:00, the patient experienced stuffed nose, joint/muscle soreness on various parts of the body, fatigue, metallic taste and smell, loss of appetite, nite sweats, hot flashes, minor headache, and weakness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events stuffed nose, joint/muscle soreness on various parts of the body, fatigue, metallic taste and smell, loss of appetite, nite sweats, hot flashes, minor headache, and weakness was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fridge temperature excursion 06/20/23; 6hrs 34min; 06/20/23/second excursion on 07/03/23; 41 hrs; 07/05/23; This spontaneous safety report, with reference number 02430701 (Interaction # 02429417) was received by the partner on 18-AUG-2023 and forwarded on 22-AUG-2023, from a health professional.  Due to the nature of the event, the causality between the event "Fridge temperature excursion 06/20/23; 6hrs 34min; 06/20/23/second excursion on 07/03/23; 41 hrs; 07/05/23" and Vaxelis was not applicable.  Further information is expected.
dx:large cerebellar hemorrhage treatment: craniotomy, EVD outcome: poor, withdrawls from pain, CHF with EF 25-30%, Hospice consulted
Platelets low, blood work performed 4/12. Platelets at 97 with comments, "Actual platelet count may be somewhat higher than reported due to aggregation of platelets in this sample. Platelets appear clumped." Platelets re-tested on 4/26 and were low again, at 94, with same commentary as above.
received a shipment of Fluzone that had been too long in transit. One of the vaccines was administered to an employee before they realized it was too long in transit, no AE; received a shipment of Fluzone that had been too long in transit. One of the vaccines was administered to an employee before they realized it was too long in transit, no AE; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/ non health care professional (office staff).  This case involves a 39 years old female patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] Lot # UT6719KA, exp; 30-JUN-2020 via intramuscular route in unknown administration site on 12-Nov-2019.  Medical history, past treatment, family history and concomitant therapies were unknown.  It was a case of actual medication error due to product distribution issue and product storage error.  It was reported that they received a shipment of Fluzone that had been too long in transit. One of the vaccines was administered to an employee before they realized it was too long in transit.   No adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
headache; fever; severe swelling in her lips; This is a spontaneous report from a contactable other healthcare professional. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration from 23Dec2020 16:30 at single dose for COVID-19 immunization. The patient's medical history included Crohn's disease. Concomitant medications included paroxetine hydrochloride (PAXIL) and spironolactone. The patient previously took morphine and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient was injected with hyaluronic acid lip filler 10 days prior to her vaccine. The patient developed severe swelling in her lips a few hours after she received the vaccine on 23Dec2020. The following day after her vaccine she developed headache and fever too (24Dec2020). The patient went to the Emergency room/department or urgent care and was treated with Benadryl. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.  Information about lot/batch number has been requested.
Post vax, the pt developed an extended localized reaction of left anterior thigh consisting of redness, swelling, and warmth. Restless and not eating well today. Prescribed Zyrtec.
Vaccination card wan't completely filled out with 1 st dose info. I asked if he got Pfizer, he said " yes, Pfizer". I gave him the pfizer vaccine and explained what to expect. He nodded, then told me " no comprendo" I gave the card to the drawer and found his 1st dose was MODERNA, not Pfizer and was given 4/9/21. We obtained an interpreter from registration and explained to him.
It is now more than 48 hours later and I have headache, low-grade fever, shortness of breath, coughing, sore throat, aches, general malaise. I have tested myself for Covid and that is negative. The reason I am reporting this is because I received Prevnar 13 a year ago and should have received the Pneumovax 23 vaccine as a folo. They were out of the 23. I realize the CDC has approved Prevnar 20 if Pneumovax 23 is not available, but I do not know if anyone has studied the side effects of that substitution.
This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a pharmacist concerning a 14 year old female with a history of asthma and multiple allergies (dust mites, grass, weeds, and others) who on 14-OCT-2007 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included influenza virus vaccine (unspecified) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) in the other deltoid. On 17-OCT-2007 the patient experienced a minor rash. On 18-OCT-2007 the rash increased to go all over the patient's body and she was given Benadryl. The hives were reappearing on and off by day 5. On 19-Oct-2007 the patient was ok, however later that evening the patient got hives and took BENADRYL again. The patient was taken to the pediatirician on 20-Oct-2007 and was told to take BENADRYL "around the clock". On 22-OCT-2007 the patient got hives again, and one big hive, "the size of a pencil eraser" appeared at the injection site. After an additional dose of BENADRYL, the hives resolved. MENACTRA and flu vaccines were administered in the other deltoid at the same visit. The patient has not been tested for any yeast allergies. Additional information has been requested.
Later that day after receiving the shot, patient reportedly became very ill with fever, vomiting, and diarrhea.  He was found deceased the next day when friends went to check on him.
PATIENT RECEIVED ONLY A PARTIAL DOSE OF VACCINE DUE TO MALFUNCTIONING SYRINGE/NEEDLE.; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced subject received only a partial dose of vaccine due to malfunctioning syringe/needle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient received only a partial dose of vaccine due to malfunctioning syringe/needle was not reported. This report was non-serious.
Dizziness + lightheaded, off and on for the past 8 days. Cold hands, left arm pain.
Went to sleep and woke up and was struggling to breathe. Apparently tried to get out of bed and passed out. Hit head and had 9 stitches in bridge of nose.
My ears are ringing constantly; My eyesight changed and I can't see out of my glasses./vision is so bad I cannot drive; Eyes are blurry; Nausea; Couldn't keep food down; Dizzy; can't get balance; Couldn't sleep for five days; Sore throat; runny nose; 1st dose: 24Mar2021, 2nd dose: 24Mar2021; 1st dose: 24Mar2021, 2nd dose: 24Mar2021; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 (Lot Number: SJCFR EN 6199) on 24Mar2021 09:00 as single dose, and dose 2 (Lot Number: En6199) on 24Mar2021 (to be confirmed) as single dose, both via an unspecified route of administration, administered in left arm for covid-19 immunization. Medical history and concomitant medications were not reported. The patient has no history of COVID prior vaccination. She has not been tested for COVID after vaccination. On 31Mar2021, the patient reported that her ears were ringing constantly, her eyesight changed, and she couldn't see out of her glasses. Her eyes were blurry, and vision was so bad she cannot drive. She had nausea for a week straight. She also couldn't keep food down. She was dizzy and couldn't get balance. She also couldn't sleep for five days. She also had sore throat, and runny nose for a week. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and has caused disability or permanent damages. Treatment for the events included prednisone and anti-nausea medicine. The outcome of the events was not recovered.
Temperature 104.7 (oral); fussiness resolved over next 3 days nonfocal examination.
pt recv vax & 4 months p/vax tested positive for antigen & neg for surface antibody;pt had been antigen negative prior to that time;No further details were provided;
This spontaneous report has been received from a physician via company representative referring to a female patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 in the right arm for prophylaxis (strength, dose, route, lot number and expiration date were not provided). On an unknown date, "approximately 4 days after vaccination", the patient's arm was swollen, red and there was a painful knot. The outcome of peripheral swelling, nodule and erythema was unknown. The causality assessment between therapy with GARDASIL 9 and the events was not reported.
Two days afterward, I had chills, achiness, dry cough, and fever. Those lasted two days.