chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; BRONCHITIS; This spontaneous report received from a consumer (patient's husband) concerned a 43 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of report.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered at Left Deltoid on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient was given a dose of the vaccine and she did not show up. On next day 10-APR-2021, she started shivering very badly and was feverish. On 11-APR-2021, the patient also had a headache. On 12-APR-2021, all symptoms gone. The next day on 13-APR-2021 when she got up she had chest tightness and went to doctor due to fever, chills, headache resumed. Since that day was the clot information in the news and they did testing for clot stuff which was all negative. Also the patient diagnosed with bronchitis. After the 13th she had 'on/off' days of experiencing symptoms. On 16-APR-2021, she tested for covid-19 via 'non-rapid' test and the results of test came on the 17th were positive for covid-19 (diarrhea, vomiting, chest tightness, shivering, chills, headache, feverish and nausea). On 17-APR-2021, she developed diarrhea and vomiting. By the 19-APR-2021, they went to the hospital where she received unspecified fluids and pain pills for the fever and to calm her down.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bronchitis and covid-19 was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210443606 - Covid-19 vaccine ad26.cov2.s-Covid 19. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Nausea, restless - unable to sleep, joint pain especially hip pain-right and left, ringing in ears.
first dose of Shingrix over 2 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date 2 years ago, prior to reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix,  which led to incomplete course of vaccination. The reporter asked if 2nd dose should be administered or needs to restart the series. The reporter was unable to provide the vaccine details (date of administration, lot number and expiration date). The reporter did not consent to follow up.
Dizzy on standing with pains on right side of head and pain in feet and legs.  Dr. Found low blood platelets and treated with steroids and fluids.
second booster dose  of MENACTRA was given to the patient; MENACTRA was scheduled to be delivered on 5/31/19, but they did not get the vaccine until 6/4/19 and when they opened ice packs were in the container but it was not frozen; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA193300, 2019SA193301, 2019SA193302, 2019SA193303, 2019SA193304, 2019SA193305, 2019SA193307 and 2019SA158240 (same reporter).  This case involves an 18 years old female patient with who was vaccinated with 0.5 ml second booster dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6365AA and expiry date was not reported) via intramuscular route in the arm NOS, on 31-May-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage and Extra dose administered.  It was reported that MENACTRA was scheduled to be delivered on 31-May-2019. Caller stated they did not get the vaccine until 04-Jun-2019. Caller stated when they opened ice packs were in the container but it was not frozen. It was stored incorrectly from 31-May-2019 to 09-Jun-2019.  At the time of reporting, no adverse reaction was reported.  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 Directive and Module VI of the 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.   List of document held by sender: none.
was administrated with Havrix after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old male patient who received HAV (Havrix) (batch number 7hj74, expiry date 21st August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th July 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was administrated with Havrix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case was 1 of 29 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter
Immediately after the vaccine, I experienced injection-site soreness. Approximately 12 hours after receiving the vaccine, I began to experience body ache, fatigue, headache, nausea, and intermittent vertigo. These symptoms lasted for approximately 18 hours, and were treated with  acetaminophen, naproxen, Zofran, heat, rest, and hydration. The following day, the vertigo and nausea returned and  intensified after I attempted to drive. Symptoms lasted approximately 3 hours. The day after that, these symptoms returned under similar circumstances. The vertigo is presently being treated with meclizine.
low grade temp (not taken) 2 days p/vax pt seemed tired; 7 days p/vax t105-seen in ER 16JUN93 dx cold & nasal discharge rx ATB; rash on face & stomach 9 days p/vax; MD visit 29JUn dx tonsillitis, allergic, rhinitis;
The patient experienced weakness, muscle pain and strong tailbone pain.  The tailbone pain started one month after injection with the Shingrix vaccine. From September the tailbone pain got worse and it is still strong.  An MRI showed no abnormalities. The pain interferes with her sleep and normal activities.
COVID positive by PCR/Symptoms include fever, headache, chill, cough, sore throat, little runny nose, nasal congestion; COVID positive by PCR/Symptoms include fever, headache, chill, cough, sore throat, little runny nose, nasal congestion; Third dose administered; This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 27Oct2021 (Lot number: FF8841) at the age of 29 years as dose 3 (booster), single, administered in arm left, administration date 23Feb2021 (Lot number: EN5318) at the age of 28 years as dose 2, single and administered in arm left, administration date 02Feb2021 (Lot number: EN5318) at the age of 28 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 27Oct2021, outcome "unknown", described as "Third dose administered"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovering" and all described as "COVID positive by PCR/Symptoms include fever, headache, chill, cough, sore throat, little runny nose, nasal congestion". The patient underwent the following laboratory tests and procedures: COVID-19 virus test test: (Mar2021) negative, notes: Nasal Swab; (24Aug2021) negative, notes: Nasal Swab; (26Dec2021) positive, notes: by PCR. Clinical course details: COVID positive by PCR. Symptoms include fever, headache, chill, cough, and sore throat. A little runny nose and nasal congestion. The patient had no COVID prior to vaccination.   No follow-up attempts are possible. No further information is expected.
felt hard lump on the bottom lip; Swelling occur 1inch below lump on the bottom lip; swelling on legs; rash on legs; hardness, lump, rash on legs; hardness, lump, rash on legs; Rash on legs; itchiness in arm; bright red swelling; hardness; bruise 3.5 by 3.5inches; exhausted; nausea; redness around injection site; Hardness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness around injection site), VACCINATION SITE INDURATION (Hardness at injection site), FATIGUE (exhausted), NAUSEA (nausea) and PRURITUS (itchiness in arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness around injection site) and VACCINATION SITE INDURATION (Hardness at injection site). On 19-Jan-2021, the patient experienced FATIGUE (exhausted) and NAUSEA (nausea). On 22-Jan-2021, the patient experienced PRURITUS (itchiness in arm), SWELLING (bright red swelling), INDURATION (hardness) and CONTUSION (bruise 3.5 by 3.5inches). On 31-Jan-2021, the patient experienced INDURATION (hardness, lump, rash on legs), LIMB MASS (hardness, lump, rash on legs), RASH (Rash on legs), PERIPHERAL SWELLING (swelling on legs) and RASH (rash on legs). On 03-Feb-2021, the patient experienced SKIN MASS (felt hard lump on the bottom lip) and LIP SWELLING (Swelling occur 1inch below lump on the bottom lip). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) for Adverse event following immunisation, at an unspecified dose and frequency. On 17-Jan-2021, VACCINATION SITE ERYTHEMA (redness around injection site) and VACCINATION SITE INDURATION (Hardness at injection site) had resolved. On 23-Jan-2021, FATIGUE (exhausted), NAUSEA (nausea), PRURITUS (itchiness in arm), SWELLING (bright red swelling), INDURATION (hardness) and CONTUSION (bruise 3.5 by 3.5inches) had resolved. On 02-Feb-2021, INDURATION (hardness, lump, rash on legs), LIMB MASS (hardness, lump, rash on legs), RASH (Rash on legs), PERIPHERAL SWELLING (swelling on legs) and RASH (rash on legs) had resolved. At the time of the report, SKIN MASS (felt hard lump on the bottom lip) and LIP SWELLING (Swelling occur 1inch below lump on the bottom lip) 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
This spontaneous report as received from a registered nurse a via company representative refers to a 59 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with ZOSTAVAX injection (dose, lot# and expiration date were not reported) for prophylaxis. On an unknown date, one week after vaccination, the patient developed shingles.  The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to 19 patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 17-MAR-2016 an unspecified number of GARDASIL 9 were under 31.1 F for 16 hours without previous temperature excursion. It was because of a data logger and the temperature were back in range. On unknown dates in 2016, the patients were vaccinated with the improperly stored GARDASIL 9 (lot# L019297, expiration date 18-AUG-2017,  route, dose and strength were not reported). No adverse symptoms were reported. Additional information has been requested.
Temp 102.9 for 3 days, papular rash for 1 day. Rash diffuse torso and scalp.
I had burning and cramping when I urinated. Pains in the bottom left side of my stomach and sometimes the right side too.
After the 2nd dose, I experienced flu-like symptoms. I had fever and muscle pain all over for one and a half day.  I was basically bed ridden.  Then after 2 weeks of my 2nd dose, I felt muscle pain again like the time of the vaccination. My arms and legs feels so tired and heavy, thus I feel weak and somehow light headed. No fever, but the weak body.  I hope if this is a side effect of Moderna, this will go away and will not affect me permanently.
No adverse event reported; the patient inadvertently received an expired dose of VARIVAX; Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided. Concomitant therapies included sterile diluent.  On 07-FEB-2020, the patient inadvertently received an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R002508, expiration date 25-JAN-2020; strength, route, frequency unknown) for prophylaxis (expired product administered). No adverse event was reported.
pt recv vax 19OCT95 & w/in 15-20min of vax pt devel hives @ inj site (rt thigh);this is 1 of 3 patients @ this site who exp the above rxn;no other details known as of the date of this report
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Medium, Additional Details: Fainted shortly after receiving Moderna booster. First 2 doses had been Pfizer. Patient reported almost fainting after Pfizer but not until after event. Hit forehead on hard floor, had a small cut, will probably bruise. Severe sweating. EMTs performed heart monitoring and decided to admit to hospital. Heart rate was measured as low as 38 BPM
patient's wife claimed that after he received the shot, he developed a bad fever (105 F) later night and ends up in ER. Doctors cannot figure out the reason why. There is no other unusual things he did on that day. So the wife is thinking the flu shot gave him the fever.
Arm swelled the evening of shot and large area surrounding injection site turned red. Now 1 week later arm severely itches.
One day post vax, the pt developed urticarial rash. Pt otherwise stable.
Information has been received from a health professional concerning a patient who on 21 JUN 2000 was vaccinated with varicella virus vaccine live (lot #634506/1770J). On approximately 29 JUN 2001 the patient experienced more than 50 lesions. The patient was not yet seen by a physician. It was also reported that unspecified medical attention was sought. It was noted that the patient's three cousins (WAES #'s 01071354; 01071705; 01071707) had similar experiences after receiving varicella virus vaccine live. No further information has been provided. Additional information has been request
3 days of general achiness, lightheadedness and nervousness. Ringing of the ears - still present of this report.
Pt recv vax on 10/8/98; on 10/12/98 pt exp crying, fever (105), vomit, eyes rolling back, jerking; pt to E.R., dx=pink ears; tx=Amoxicillin, T 105 in ER
12 month vaccination given, 15  minutes after shots noticed fine raised red rash in face. Observed for 15 minutes notice started to spread. BENADRYL IM given per protocol.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. The reporter reported the patient received the third dose in the GARDASIL 9 (intramuscularly for prophylaxis; strength, dose, lot number and expiration date were not provided) series more than a year after the second dose (inappropriate schedule of vaccine administration). No adverse effects were reported.
Woke up at 3:30 AM 6.5 days after the 3rd Pfizer vaccine with my first ever occurrence of what was diagnosed as Paroxysmal Atrial Fibrillation. Symptoms were feeling of fluttering in the chest and mild weakness. Was given Cardizem IV and converted to normal sinus rhythm in the ER. Was admitted inpatient for observation and tests.
Lost taste; Lost smell; Runny nose; Head cold; Headache; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost taste), ANOSMIA (Lost smell), RHINORRHEA (Runny nose), NASOPHARYNGITIS (Head cold) and HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced RHINORRHEA (Runny nose), NASOPHARYNGITIS (Head cold) and HEADACHE (Headache). On 30-May-2021, the patient experienced AGEUSIA (Lost taste) and ANOSMIA (Lost smell). At the time of the report, AGEUSIA (Lost taste), ANOSMIA (Lost smell), RHINORRHEA (Runny nose), NASOPHARYNGITIS (Head cold) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was reported.  Patient  tested positive for covid after receiving both doses of the vaccine and wanted to know if this has happened to others.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Patient reported that she will confirm the batch lot and inform.
Reported pt diagnosed with Guillain-Barre syndrome. Per 1 year ago: Pt has not recovered. "Continues to be off-balance. Bottoms of my feet are painful and they tingle with my toes wanting to draw under. My hands still tingle."
Pt came in store 11-17-18 indicated that he received a flu shot and his shoulder in now hurting. He indicated initally he had a knot as site of injection and now his shoulder is hurting. Pt indicated he is going to see his pcp as a follow up.
Pt started developing lumps on her armpit, pain spreading through entire left chest area. The symptoms started few hours after vaccination. The lump  disappeared few days after which patient cannot remember exactly.  Patient doesn't have any lump now (1/29/22), but she still has very sore arm and pain radiating through her entire left upper side of the body.  Her doctor said to take Tylenol for it and she had been taking Tylenol everyday
1 day later, patient developed a rash that is approximately 3 inches in diameter. Warm to touch. Patient used hydrocortisone cream and is slowly experiencing relief. Will take BENADRYL at night.
Patient with 3 COVID vaccines who admitted to hospital with positive COVID detected PCR.  Provider d/c note:  " 61 YO woman with history of diabetes type II, HLD, IBS and sigmoid colectomy in 2020 for diverticulitis, who presented to the ED for abdominal pain and multiple episodes of BRBPR in setting of COVID-19 infection. CT scan demonstrated findings of infectious/inflammatory colitis extending from the splenic flexure through the rectum, associated with leukocytosis, AKI, mild hyponatremia. She was treated with IV cipro/flagyl, IV fluids, and bowel rest. Surgery was consulted for colonoscopy. She initially had resolution of diarrhea and significant improvement in pain while on a clear liquid diet, however symptoms returned when diet was advanced. Due to recurrent symptoms, she underwent colonoscopy on 11/5. This demonstrated inflammation from the end-to-end colonic anastomosis through the sigmoid and descending colon. Biopsies were taken and pending at time of discharge. She did much better with diet advancement following the procedure. Will discharge home to complete 7 day course of antibiotics. Advised to stay well hydrated and return precautions discussed.  She will follow-up with Dr. in about 10 days and she will call her PCP tomorrow to schedule hospital follow-up as well. "
Shingles 2 days after 1st shot; I get cold sores; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 50-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 3 times).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles and cold sores. On an unknown date, the outcome of the shingles was unknown and the outcome of the cold sores was not recovered/not resolved.   It was unknown if the reporter considered the shingles and cold sores to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced shingles 2 days later the vaccination. The patient stated that needless to say he/she didn't get the 2nd dose, So he/she had them 4 times. The patient also stated that now he/she got cold sores, which he/she hadn't had until that 1st shot. Additional supportive information: The follow-up would not possible, as no contact, details were available.