chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a register nurse via company representative, refers to a female patient of unknown age. Co-suspect and concomitant therapies were not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, lot number, expiration date, strength and route were not reported). Co-suspect and concomitant therapies were not reported. The patient's mother stated that on an unknown date, the patient experienced warts on the bottom of her feet. At the time of the report the outcome was unknown. The patient seek medical attention with a podiatrist, who stated that the warts were caused by GARDASIL. This case is one (1) of two (2) reports from the same reporter (1405USA004510). Additional information is not expected.
axilla pain, swelling and discomfort that radiated to breast after 1st dose. Ibuprofen helped some but did not get rid of pain. persisted for 3 weeks after 1st dose
Patient experiencing severe pain at injection site and arm pain.  Patient applied ice and used over the counter meds but arm is still in pain after 2 weeks of vaccination.
THREW UP TWICE; FEVER; This spontaneous report received from a patient via a company representative 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced threw up twice, and fever.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and threw up twice was not reported. This report was non-serious.
This spontaneous report as received from a physician via a company representative refers to an 11 year old female patient with no pertinent medical history. The patient received her second dose of GARDASIL (lot# and dose not reported, route reported as injection) in October 2014. On 19-NOV-2014 the patient came into the office for her third dose of GARDASIL and she was vaccinated with her third dose of GARDASIL (lot# and dose not reported, route reported as injection) which was outside of the prescribing information recommendation on the same day. The patient took no concomitant medication. No treatment was given for the event. The patient did not seek medical attention and no lab diagnostics studies were performed. The outcome of the event was not reported. Additional information has been requested.
Runny nose and headaches for a full week after the vaccine. Loss of taste on 8/5 and tested positive for SARS-CoV-2 on 8/6.
Severe balance issues resulting in inability to walk without a cane or perform simple household or personal care activities. Referred to ENT specialist who have me exercises to dislodge crystals in inner causing situation.  90% effective and should resolve with additional time.
Multiple Papules in various stages (some with small blisters on top, some with scabs, some red papules all one lesions) papules dispersed over ABD, back, arms, legs, face (mild). Positive itching during exam.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever that is up and down and not past 103 degrees) and CHILLS (Chills) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 025B21A) for COVID-19 vaccination.No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced PYREXIA (Fever that is up and down and not past 103 degrees) and CHILLS (Chills). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, PYREXIA (Fever that is up and down and not past 103 degrees) and CHILLS (Chills) had not resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Body temperature: 103 (High) Up and down fever not past 103 degrees. Concomitant product use was not provided. Action taken with mRNA-1273 in response to the events was  not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to US-MODERNATX, INC.-MOD-2021-127262 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-127262:Wife
went to get the second booster, and got .05ml instead of .25ml, because there were negligence when they were processing the syringes; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (went to get the second booster, and got .05ml instead of .25ml, because there were negligence when they were processing the syringes) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .05 milliliter. On 14-Apr-2022, the patient experienced ACCIDENTAL UNDERDOSE (went to get the second booster, and got .05ml instead of .25ml, because there were negligence when they were processing the syringes). At the time of the report, ACCIDENTAL UNDERDOSE (went to get the second booster, and got .05ml instead of .25ml, because there were negligence when they were processing the syringes) outcome was unknown.     No concomitant drug was reported. The patient received second booster dose. The reporter stated that 45 minutes later she was ask to go back to the clinic and get a 0.2 ml doses to complete their dosages of a booster. The patient did not have side effects. No treatment drug was reported.   This case was linked to MOD-2022-557647 (Patient Link).   Reporter did not allow further contact
Patient experience shortness of breath,  nausea, weakness, chest pain & pressure so patient went to emergency room
This spontaneous report as received from a medical assistant refers to 4 children patients of unknown age and gender. On an unknown date those patients were vaccinated with an improperly stored PEDVAXHIB (dose, units, route of administration, anatomical location, lot number were not reported). No adverse effects were reported at the time of reporting. Follow up information has been received from a medical assistant. This report refers to 1 year old patient. On 15-AUG-2014 the patient was vaccinated with PEDVAXHIB (lot no. J01343, expiry: 14-AUG-2016). No concomitant medication was reported. On an unknown date the patient was vaccinated with improperly stored PEDVAXHIB. No adverse effects were reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Weakness; Hot flashes; Nauseous; Vomiting; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), HOT FLUSH (Hot flashes), NAUSEA (Nauseous), VOMITING (Vomiting) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immune system disorder (NOS) (compromised).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness), HOT FLUSH (Hot flashes), NAUSEA (Nauseous), VOMITING (Vomiting) and HEADACHE (Headache). At the time of the report, ASTHENIA (Weakness), HOT FLUSH (Hot flashes), NAUSEA (Nauseous), VOMITING (Vomiting) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
?Janssen COVID-19 Vaccine EUA" About 3 minutes after administration was experiencing lightheadedness, dizziness, and blurred vision. Turned very pale and heart rate dropped to 47.  About 8 hours after administration body aches and body temperature began to rise.
This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 21-OCT-2013 at 15:00 the patient was administered with a MMR II (lot number J002505, expiry date 28-FEB-2015) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date the MMR II was exposed approximately for 9.5 hours at temperature of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17:14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13:25 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7 degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
Chills; Sore arm at the injection site; a low grade temperature; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), VACCINATION SITE PAIN (Sore arm at the injection site) and PYREXIA (a low grade temperature) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced CHILLS (Chills), VACCINATION SITE PAIN (Sore arm at the injection site) and PYREXIA (a low grade temperature). At the time of the report, CHILLS (Chills), VACCINATION SITE PAIN (Sore arm at the injection site) and PYREXIA (a low grade temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: email updated. The reporter was changed from health care professional to consumer on follow-up.
Pt's arm red, swollen, and warm to touch.  Pt advised to use ice packs.
Arm tingle a few minutes after 2nd vaccine; Next day sore arm; 100.8 fever/ Fever lasted 12 hours; Then itchy and swollen arm end of day 3; Then itchy and swollen arm end of day 3; This is a spontaneous report from a non-contactable consumer (patient). A 54-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided), via an unspecified route of administration in left arm on 03Mar2021 at 15:30 (at the age of 54-years-old) as a single dose for covid-19 immunisation. Patient had known allergy to neomycin. Medical history included chronic venous insufficiency (CVI) and lymphedema. Concomitant medication included apixaban (ELIQUIS) and acetylsalicylic acid (ASPIRIN). Patient did not receive other vaccine in four weeks of vaccination. Other medication in two weeks included apixaban (ELIQUIS) and acetylsalicylic acid (ASPIRIN). Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. Patient had previously received first dose of vaccine in left arm on 09Feb2021. On 04Mar2021 at 12:00, arm tingle a few minutes after 2nd vaccine. Next day sore arm and 100.8 fever lasted 12 hours. Then itchy and swollen arm end of day 3. Need a Benadryl. No treatment was received. The outcome of all events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Third dose in a 2-dose series.   First dose was administered 1/13/2021. Second dose was administered 2/9/2021.
red blotch with lump on left arm, black and blue marks left leg, itchy little bumps, top left foot, very black and blue on top of right foot going on to toes      took pictures on my cell phone
RIGHT ARM STILL SWOLLEN WITH VISIBLE RED WELT WITH ITCHINNG 11 DAYS AFTER RECEIVING
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) and fatigue in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19  vaccine) for COVID-19 immunization. No medical history reported. On Mar 22, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 23, 2021, patient experienced pain in extremity (sore arm) and fatigue. At the time of the report, pain in extremity (sore arm) and fatigue outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored VAQTA lot # M039202 with expiration date of 11-MAR-2018, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit (°F) for 2 hours. Data logger was involved. There were not previous excursions. No adverse symptoms were reported. No other information was provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA002222: US-009507513-1705USA002242: US-009507513-1705USA002243.
ACTHIB was reconstituted with sterile water; Initial information received on 24-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 1 years old male patient who had acthib was reconstituted with sterile water while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL); INFLUENZA VACCINE (INFLUENZA VACCINE); and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  On 23-Feb-2022, the patient received a  dose of suspect HIB (PRP/T) VACCINE with the dose of 0.25 mL to 2 mL for vaccines,lot UJ614AB via intramuscular route for immunization.  On 23-FEB-2022 the patient developed a non-serious acthib was reconstituted with sterile water (medication error) following the administration of HIB (PRP/T) VACCINE.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event (ACTHIB was reconstituted with sterile water).  At time of reporting, the outcome was Unknown for the event acthib was reconstituted with sterile water.  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.
pain at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown.        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.   Treatment medication a Cream (Unknown drug).
After taking the shot, the right side of the head started to get hotter than the left. And the right ear started to open and close and then after a while I couldn't even pop it open. It was like a stuffiness in the ear. The lymph nodes on that side felt enlarged. So I called the allergist and felt like I had sinusitis. But then I had a headache and it was only on one side of the head. So I called the doctor and we agreed to a telehealth visit and described what happened and how I had just taken the shot. He asked if I had taken Moderna and he said that when he went to an ENT, he had the same reaction. I was the only other person he knew who had the same reaction (his symptoms lasted 6 months). He said to ride it out, and he did offer steroids, but it would compromise the building of immunity. He said if it was only on one side, to just ride it out. I let him know that I would drink a lot of cold things, and hydrate. I wanted to verify that it wasn't something that I could pass on to children as a contagion, and he said that as long as there's no fever or cough, I could go in to work. He added AYRS, nasal spray that would help hydrate the sinuses. Duration was probably anywhere from 2-3 months, but took 4 months to completely recover- symptom free. Ear would open regularly, and I could pop it open. It wasn't as bad of a headache, and drainage stopped. Added peppermint capsules to my regime to help with symptoms.
fever/102.3 temperature; headache; achy all over; Within 3 minutes had tingling pins in mouth tongue and throat; Within 3 minutes had tingling pins in mouth tongue and throat; had hard time breathing; O2 sat were at 91; i had High BP 148/92; severe fatigue; This is a spontaneous report from a contactable Other HCP (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EJ1686), via an unspecified route of administration on 05Jan2021 07:00 at single dose on the left arm for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), asthma, depression, irritable bowel syndrome (IBS), known allergies included bacitracin, penicillin, levofloxacin (LEVAQUIN), metronidazole (FLAGYL), oseltamivir phosphate (TAMIFLU), Bees, Hornets. Patient took other medications in two weeks. No other vaccine received in four weeks. Patient was not pregnant. Facility type vaccine was hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Jan2021 07:03, within 3 minutes patient had tingling pins in mouth tongue and throat, had hard time breathing. The nurses gave her 50 mg of diphenhydramine hydrochloride (BENADRYL). The doctors checked her O2 sat were at 91, and she had High BP 148/92. After 40 minutes (05Jan2021 07:43) after the medication her symptoms seem to go away and she could breath better. She went home and went to bed because she work night shift. She got the vaccine when she got off work, then about six hours later (05Jan2021 13:00) she had bad headache and achy all over, 12 hours later (05Jan2021 19:00) she had 102.3 temperature and took paracetamol (TYLENOL) every 4 hours and fever finally broke 26 hours later (06Jan2021 21:00). She continued to have a headache for about 5 days and severe fatigue. Adverse event resulted in life threatening illness (immediate risk of death from the event). Patient was recovered with lasting effects.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported  life threatening events including tingling pins in mouth tongue and throat, had hard time breathing, PO2 decreased, blood pressure increased, bad headache, achy all over, fever, and severe fatigue, and the administration of the COVID 19 vaccine, BNT162B2, considering the plausible temporal association.   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 RA, IEC, as appropriate.
Patient reported swollen lymph nodes in the axillary region several hours after receiving the second dose of the Moderna vaccine.  He describes that in addition to the swollen lymph nodes, he experienced pain and inflammation in the axillary region, which did not respond to the use of ibuprofen. Additionally, he also reports a loss of sense of taste shortly after receiving the vaccine and dizziness/fatigue that persisted for about 3 days after his vaccination.
Anaphylactic Reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic Reaction) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic Reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic Reaction) outcome was unknown.        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.  Treatment information was unknown.  Very limited information regarding this event has been provided at this time. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Fever to 101.4, chills body aches, fatigue for 24 hours.