chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Costochondritis (chest wall inflammation). Had to visit ER and cardiologist and underwent CT, Echo, blood tests to rule out heart issues. Pain has lasted for at least 4 weeks and is still here. Will not get vaccine again in the future because of the pain caused.
legs achy; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PAIN IN EXTREMITY (legs achy) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0258218) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 09-Mar-2021, the patient experienced HEADACHE (headache). On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (legs achy). At the time of the report, HEADACHE (headache) and PAIN IN EXTREMITY (legs achy) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Concomitant medications were not provided.
Her hips and her knees everything was as stiff as a board and she could not bend her knee's; tingling; blood pressure was 169/101; speech was real slurred; numb in her arm and hand; she could not pick up or hold anything; This is a spontaneous report from a contactable consumer (patient herself).A 29-years-old non- female patient received receibed second dose of bnt162b2  (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 28Jan2021 as intramuscular, administered in Arm Right on 07Jan2021 as SINGLE DOSE for covid-19 immunisation.The patient medical history was not reported.The patient's concomitant medications were not reported. The patient experienced numb in her arm and hand (hypaesthesia) on 28Jan2021 10:00 and she could not pick up or hold anything on 28Jan2021 and, speech was real slurred on 30Jan2021 and , her hips and her knees everything was as stiff as a board and she could not bend her knee's on an unspecified date  and tingling (paraesthesia), blood pressure was 169/101 (blood pressure abnormal) on an unspecified date and The patient underwent lab tests and procedures which included blood pressure measurement: 169/101 on ,blood test: normal  on 30Jan2021 ,computerised tomogram: no stroke on 30Jan2021 ,urine analysis: normal on 30Jan2021.The events were considered as non-serious by the consumer The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Syncope, Flushing/sweating  Pt felt light headed, assisted to ground by RN.  Placed in wheelchair and moved to med bay.  VSS on arrival.  Pt eating and drinking w/ no issues.  Feeling normal.  Ovbserved patient to stand. Stron/steady gait.  BP 130/85, HR 93, RR 22 -- > 130/80, 81, 18.  Patient stable and released from vaccination site. Grass allergy
doses 50 days apart.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (doses 50 days apart.) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. UNK and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (doses 50 days apart.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (doses 50 days apart.) outcome was unknown.            No relevant concomitant medication was reported. Treatment medication was not provided.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally (dose number, exact dose, lot # and expiration date were not reported), for prophylaxis. No known adverse effects were reported. The administered doses ROTATEQ experienced multiple temperature excursions over unspecified time periods. The reporter did not know if digital data logger was involved to capture the temperature excursions. Previous temperature excursions were also reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000808.
VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 41 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. Age at time of vaccination 41 years old. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAY-2021, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and administration of refrozen vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537532, 20220537683, 20220537548, 20220538238, 20220539045, 20220538425, 20220538428, 20220538297, 20220538573, 20220538480, 20220538149, 20220538379, 20220538666, 20220537688, 20220540611, 20220538693, 20220540435, 20220540524, 20220540474, 20220538890, 20220540853, 20220541180, 20220540570, 20220537507, 20220538627, 20220537341, 20220537444, 20220538292, 20220538347, 20220538411, 20220537356, 20220538146, 20220538210, 20220540688, 20220540420, 20220540642, 20220540814 and 20220540765.
Sore swollen arm, back and knee pain, symptoms of UTI, light bleeding in urine.
swelling at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with dose of Shingrix, the patient experienced swelling at the injection site to about the size of an orange.
Extremely sore arm, fatigue, headache, nausea, vomiting, body aches. I was doagnosed with Covid on February 3, 2021. Yesterday when I received vaccine, it was my 84 day post Covid.
For the entire week starting the day after my second dose, I had a little fever and muscle fatigue (reported via v-safe). The fever was temporary but unlike others I had heard from, whose adverse reactions lasted a day or two, I felt fluish a weak the entire week. Exactly six weeks after ny second dose, I came down with the same temperature and fluish feeling. It's been two weeks now and the muscle and general fatigue, together with some brain fog, have persisted. I am barely able to perform as normal and have missed work and family events. I went to my doctor who took bloodwork and found some infection/inflammation markers, with nothing to point to in terms of infection.                   .
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history or drug allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) injection (Lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and route were unknown). No information on patients' concomitant medications was provided. No adverse effects were reported. Lot number L003775 had been verified to be a valid lot number for VARIVAX (Merck). Follow-up information has been received on 03-AUG-2015. All telephone attempts to obtain follow up information had been unsuccessful. Follow-up information has been received on 05-AUG-2015. The Certified Medical Assistant reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. The company fax number was reviewed with the reporter, if information becomes available. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015. The patient was 12 month old. The patient was vaccinated with improperly stored dose of VARIVAX (Merck) on 18-SEP-2015. This is one of the several reports received from the same reporter. Additional information has been requested. Patient, event, product and narrative information was updated.
At approximately 1916, patient reported lightheadedness, feeling "sweaty", and feeling "like my heart is racing". Lead nurse assessed patient. Patient denied difficulty swallowing, itchiness, rashes and hives. EMT  assessed patient vital signs: blood pressure 98/42 mmHg, pulse 50 beats/minute, and SpO2 98%. Patient reported aversion to needles and history of needles. Lead nurse offered to call 911. Patient refused needing 911. Lead nurse utilized guided breathing techniques with patient. At approximately 1925, patient reported feeling less lightheaded, sweaty, and denied feeling her heart was racing. Lead nurse continued to use guided breathing techniques. At 1935, EMT  reassessed patient vital signs: blood pressure 126/92, pulse 82 beats/minute, and SpO2 99%. Patient given water. Patient able to drink water. At 1945, EMT  reassessed patient vital signs: blood pressure 136/96 mmHg, pulse 66 beats/minute, and SpO2 99%. Lead nurse assessed patient. Patient denied lightheadedness, diaphoresis, and feeling her heart was racing. Patient reported she felt "a lot better". Lead nurse educated patient on signs/symptoms of when to seek emergency care, to sign up on v-safe and to follow up with primary care provider. Patient called family member to pick her up from facility. At approximately 1955, patient left facility with steady gait and unlabored respirations, accompanied by family member.
Fatigued the night of 4/30/21.  Woke up at 2:00am and had trouble breathing.  Checked oxygen and it was 90.  Had a fever of 102 and full body aches.   5/1/21-Chills and fever of 99 continue the following day.  Oxygen went down to 87.  elevated to 90-93.  Heart rate was up and blood pressure was low.  Light headed, nauseous.  Pale and weak.  This lasted about 4 days. 5/3/21- Sweating started and felt like knives poking through skin.   5/4/21- Rash developed under entire left arm. 5/6/21- Oxygen finally reach 97 and increased to normal.  Nausea finally subsided. Doctor said I likely had anaphylaxis and a immunologic driven reaction.
Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer (Office Staff). This case involves a six months old female patient who was vaccinated with a 0.5 ml dose of PENTACEL (route: intramuscular, site of administration: thigh NOS, batch number: DTap vial lot # C5020BA exp 6/30/2018 NDC: 49281-560-05 ACTHIB vial lot: C5384AA exp 6/30/2018 NDC: 49281-545-15) on 30-OCT-2018. Concomitant vaccination included FLUZONE QUADRIVALENT (route: intramuscular, site of administration: thigh NOS, batch number and expiration date was not reported) on 30-OCT-2018. The patients medical history were not reported. It was an actual medication error due to expired vaccine used (administered expired pentacel to a female patient). It was unknown whether patient experienced any adverse event following vaccination. 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. List of documents held by sender: none.
Started as Red Ring above elbow later yesterday afternoon. As day progressed upper arm completely became red, hot and swollen.
PATIENT WAS TO RECEIVE 0.25ML BOOSTER DOSE BUT INSTEAD RECEIVED FULL 0.5ML DOSE. NO ADVERSE AFFECTS REPORTED BY PATIENT WHEN NOTIFIED.
She had burning in nose.; She could taste chemical in her mouth.; Within 42 to 78 hours after 1st and 2nd dose, she had constant menstrual bleeding that heavy with large blood clots/She is still bleeding heavily; She had mild fatigue on same day and following day after 1st dose and 2nd dose.; She started with immediate burning and pain at injection site.; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (She had burning in nose.), DYSGEUSIA (She could taste chemical in her mouth.), HEAVY MENSTRUAL BLEEDING (Within 42 to 78 hours after 1st and 2nd dose, she had constant menstrual bleeding that heavy with large blood clots/She is still bleeding heavily), FATIGUE (She had mild fatigue on same day and following day after 1st dose and 2nd dose.) and VACCINATION SITE PAIN (She started with immediate burning and pain at injection site.) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 9399021A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and IRON for an unknown indication.    On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL DISCOMFORT (She had burning in nose.), DYSGEUSIA (She could taste chemical in her mouth.), HEAVY MENSTRUAL BLEEDING (Within 42 to 78 hours after 1st and 2nd dose, she had constant menstrual bleeding that heavy with large blood clots/She is still bleeding heavily), FATIGUE (She had mild fatigue on same day and following day after 1st dose and 2nd dose.) and VACCINATION SITE PAIN (She started with immediate burning and pain at injection site.). At the time of the report, NASAL DISCOMFORT (She had burning in nose.), DYSGEUSIA (She could taste chemical in her mouth.), HEAVY MENSTRUAL BLEEDING (Within 42 to 78 hours after 1st and 2nd dose, she had constant menstrual bleeding that heavy with large blood clots/She is still bleeding heavily), FATIGUE (She had mild fatigue on same day and following day after 1st dose and 2nd dose.) and VACCINATION SITE PAIN (She started with immediate burning and pain at injection site.) outcome was unknown.            Treatment information was included birth control.   This case was linked to MOD-2021-313046.
PT REPORTED FLUSHING & REDNESS ON NECK 4 HRS AFTER MODERNA 4 hrs after vaccine, pt reported flushing & redness on neck, no fever, BP ok
Initial and follow-up information has been received from a physician and a registered nurse concerning a 18 week old male infant, with no medical history or no drug reactions/allergies, who on 09-MAY-2006 was vaccinated intramuscularly in the right leg with a second dose of Pneumovax (Lot # 650649/0790F). Concomitant therapy, received 09-MAY-2005 intramuscular included second dose of each: DTaP (AVENTIS C2254AA) in the left leg, ActHIB Aventis VE610AA) in the left leg, and IPOL AVENTIS Y0535 in the right leg. The nurse initially reported that this was a "prescription error". She explained that this was a new practice, and they had no Prevnar, but they did have Pneumovax 23, so Pneumovax 23 vaccine was ordered and that is what the baby received. She stated that normally they would wait for the Prevnar to come in. She further stated the physician called the child's parents and that no symptoms of any kind were noted. Follow up information from the physician indicated that the patient on 10-MAY-2006 developed a mild temperature to 100 degree. The patient subsequently recovered on 11-MAY-2006. It was reported that there was no illness at the time of vaccination and no diagnostic tests were performed. No product quality complaint was involved. Additional information is not expected.
4 days after 2nd dose:  hives all over my body and swelling of face and eyes.  Called Telemedicine at Urgent Care Huntsville Hospital.  Was given instructions to take 40 mg of Prednisone first day and taper off, 2-3 doses of antihistamine and Hydrocortisone on welts.  Needed to go to ER for IV if face swelling did not go down.  Today (second day after call):  Face swelling is down but hives are possibly worse (large welts over large portion of body plus on hands and feet and chin)
Pt devel fever 23JUL91 dx tonsillitis 24JUL91;
Approximate date and time.  My husband and son who is three received flu shot from the same container.  When leaving the office I felt like there were bugs crawling in my arm where shot was given.  Over next couple of days the spot where shot was given was red hot, swollen and very itchy.  About four days after shot I started having itching and rash on upper abdomen.  It spread to extremities.  I was diagnosed with allergic urticaria.  The reaction lasted about 6 weeks with treatment of oral steroids.  The reaction went away and the an came back the first week of January and lasted again for another 6 weeks.  I was again on the oral steroids for two rounds.  I saw another allergist who diagnosed allergic urticaria.
At around 7PM 01/29/2021, I was at the store to get groceries when walking around the store became difficult due to being out of breathe. When I got home the body aches got worse and I started getting severe chills and could not stop shaking. That night was difficult to sleep because of the pain I was in. When I woke up the next day, 01/30/2021, I was dizzy, severe fatigue, had severe migraines, I could not breathe when standing up and moving around, my heart was racing, and it felt like I had a sun burn all over my body. I called the nursing coordinator for that day and asked what to do and she said to go to the ER. When I arrived at the ER, they said I had 100 degree temp., I was tacky. They gave me medicine for the pain and the doctor said I was having a adverse reaction to the vaccine but by the next day I would feel better. I went home and slept after the ER all day and night and by Sunday 01/31/2021, I was feeling better after excedrine and advil
Tested positive for type A flu; Initial information received on 14-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-helath care professional.  This case involves an adult patient of unknown age and gender who had tested positive for type a flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer(unknown form, route, strength, lot number and expiry date) in unknown administration site for Flu(Influenza). Information regarding batch number details has been requested.  On an unknown date the patient had a non-serious event of tested positive for type a flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported" Since this is a public post on the Sanofi flu shot campaign  we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: I got my flu shot in October. Tested positive for type A flu today."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Tested positive for type A flu).  At time of reporting, the outcome was Unknown for the event tested positive for type a flu.
Severe arm pain at injection site, sudden onset dizziness about 2 hrs after injection; the next morning, fatigue, aches & pains, extreme nausea, dizziness, passing out upon standing up (lost consciousness twice, resulting in a fall and mild head injury). For several days afterward experienced unexplained depression, not sure if it was related.
dizziness; This is a spontaneous report from a non-contactable healthcare professional. A 72 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EH9899), intramuscular on the right leg (right deltoid muscle) on 22Dec2020 17:30 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced dizziness on 22Dec2020 17:45, during her 15 minute waiting period after the injection. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. The patient was monitired for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with wheezing and dyspnea, vomiting, abdominal pain, hypotension, dysrhythmia, chest pain and collapse. On an unspecified date, the patient underwent lab tests and procedures which included blood sugar: 108 and vital signs measurement: normal. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Noticed a couple days later that my tongue was numb, I was very dizzy and had a horrible taste in my mouth. I also had sever diarrhea and body aches. I did rest for a few days and the body aches went away. The remaining symptoms lasted for weeks. The diarrhea finally went away about a month later however the other symptoms are still with me.
2SEP92 t103.9, emesis, pt in & out of sleep state & recovered in 3 days;
This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and drug reactions or allergies was provided. Between 01-JUN-2017 and 05-SEP-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # L029472 with expiration date 06-AUG-2017 and lot# M049127 with expiration date 15-DEC-2018 (dose and route of administration were not reported) reconstituted with sterile diluent (manufacturer unknown). The temperature excursion ranged from minus 14 to minus 10 degrees Celsius for 630 minutes and from minus 9 to plus 8 degrees Celsius for 3 hours. No adverse effects were reported. There was no previous temperature excursion. Digital data logger was used. Product quality complaint was not involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA007213.