chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it felt like she had the flu.; there was a red bump and the area was swollen for a week after.; there was a red bump and the area was swollen for a week after.; Sick; vomite; Aching; having no energy; sleeping all day; This case was reported by a consumer via patient support programs and described the occurrence of sickness in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced sickness, vomiting, pain, asthenia, somnolence, influenza-like symptoms, injection site swelling and injection site erythema. On an unknown date, the outcome of the sickness, vomiting, pain, asthenia, somnolence, injection site swelling and injection site erythema were recovered/resolved and the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the sickness, vomiting, pain, asthenia, somnolence, influenza-like symptoms, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient called and advise that the shingrix medication made her sick.  The patient stated that she had been vomiting, aching, having no energy, sleeping all day and the symptoms lasted 1 and half days.  The patient felt like she had the flu. The patient stated that where the pharmacist injected the vaccine, there was a red bump and the area was swollen for a week after.  The patient also stated the same thing happened both times she received the injections. For tolerance dose, reference case US2019GSK112613.; Sender's Comments: Patient called to advise that the shingrix medication made her sick. She stated she has been vomiting, aching, having no energy, sleeping all day and the symptoms lasted 1 ½ days. She stated it felt like she had the flu. Patient stated where the pharmacist injected the vaccine, there was a red bump and the area was swollen for a week after. Patient also stated the same thing happened both times she received the injections.
Mom called office 7/9/15 stating left thigh has an area that looks like a mosquito bite directly on injection site. Area is red and warm to the touch. The redness is increasing in size. Mom said area stayed red after injection given 6-29-15.
ran fever 104 on evening 4 day following vax 7MAY97;reported on 13MAY97 cont w/fever of 101-102;
Case number PHEH2016US008630, is a spontaneous report initially received from a nurse on 05 Apr 2016. This report refers to a17 years old female patient. Medical history and concomitant medication were not reported. The patient (under the age of 18) was vaccinated with FLUCELVAX (batch number: 174087A) on 01 Dec 2015, intramuscularly instead of FLUARIX (batch number: 9JX2N, expiration date: 16 Jun 2016) as the patient was supposed to receive FLUARIX. No adverse event was reported following this maladministration. Follow up report received from a nurse via fax on 22 Jun 2016: Added to co suspect vaccine (FLUARIX), added new event wrong vaccine administered and deleted the event inappropriate age at vaccine administration.
Patient seen for a nurse visit for vaccines for school. Ok to give HPV, Menveo, and flu vaccines to patient. Confirmed name and DOB with patient and father. Informed patient and father of vaccines due.   Patient and father agreed to give all vaccines. Administered HPV to LD, the flu and Menveo to RD.   After administering the vaccines, patient was Instructed to sit from the bed to the chair next to his father. After leaving the exam room, the patient had stood up to rotate his arms, fallen and possibly hit his face per the patient's father.   Entering the room, the patient had fainted and does not recall fainting and falling. Patient had a red mark on his nose from the fall.   Patient's vitals recorded:   Time: 4:18pm BP: 147/80 HR: 74 BS: 94 RR: 16 O2 Sat:  98%   At 4:21 p.m. BP: 121/69 HR: 98 RR: 16 O2 Sat: 98%   At 4:26 p.m. BP: 107/66 HR: 92   Paramedics was called and Patient will be transported to the ER.
This spontaneous report was received from a pharmacist and refers to two unspecified patients of unknown demographics. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On 10-MAR-2017, the patients were inadvertently administered an expired doses of ZOSTAVAX (19400 plaque-forming units, PFU) injection (lot # L027322 with expiration date at 21-OCT-2016; dose, route of administration and anatomical location were not reported) for prophylaxis. There was no adverse effect reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Started period 4/20/21. It is extremely heavy; Started period 4/20/21. It is extremely heavy and completely abnormal for me.; Felt like heavy menstrual cramps continually from 4/10/21 to 4/20/21; My face went numb 20 minutes after the shot.; Had arm pain for a day; Extreme fatigue; The inside of the mouth is swollen; There is a bumpy texture on the inside of  the lip.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 09:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. On 09Apr2021 at 09:50 (also reported as 09:45) 20 minutes after the shot the patient's face went numb. The patient had arm pain for a day. The patient experienced extreme fatigue, the inside of the mouth was swollen and there was a bumpy texture on the inside of the lip. On 10Apr2021, the patient experienced what felt like heavy menstrual cramps continually from 10Apr2021 to 20Apr2021. On 20Apr2021, the patient had period. It was extremely heavy and completely abnormal for the patient. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain for a day was recovered on 10Apr2021 and felt like heavy menstrual cramps continually was recovered on 20Apr2021. The clinical outcome of the events face went numb 20 minutes after the shot, extreme fatigue, inside of the mouth was swollen, bumpy texture on the inside of the lip, started period, it was extremely heavy and completely abnormal was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
First night, patient had significant pain up and down the arm.  Originally it was thought it could be an allergic reaction because it was swollen and responded to diphenhydramine.  However, it stopped responding  to that medication and was still hurting.  Patient is now stating that there is significant shoulder and neck pain that started this morning.  Her arm has been stiff since the injection.  We thought if it was an allergic reaction it would have subsided by now, but the pain is still there and she believes that the injection may have been given too high on her arm.
Dime sized hive on inner aspect of both forearms and 2 hives on back of neck. No SOB, dyspnea or swelling of mouth, lips or throat. Given Benadryl IM @ 10:55AM. Hives resolving. B/P & HR WNL.
injection site it was itchy; red and like a rush; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), VACCINATION SITE PRURITUS (injection site it was itchy) and VACCINATION SITE ERYTHEMA (red and like a rush) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore left arm). On 20-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site it was itchy) and VACCINATION SITE ERYTHEMA (red and like a rush). On 18-Jan-2021, PAIN IN EXTREMITY (sore left arm) outcome was unknown. On 24-Jan-2021, VACCINATION SITE PRURITUS (injection site it was itchy) and VACCINATION SITE ERYTHEMA (red and like a rush) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
High Blood pressure 180/117 mm of Hg; Mild headache; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (High Blood pressure 180/117 mm of Hg), HEADACHE (Mild headache) and FATIGUE (Fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included LANSOPRAZOLE (PREVACID), NITROFURANTOIN, ESCITALOPRAM OXALATE (LEXAPRO), ALPRAZOLAM, MELOXICAM, MONTELUKAST, ATORVASTATIN and HYDROCHLOROTHIAZIDE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HEADACHE (Mild headache) and FATIGUE (Fatigue). On 08-Mar-2021, the patient experienced HYPERTENSION (High Blood pressure 180/117 mm of Hg). At the time of the report, HYPERTENSION (High Blood pressure 180/117 mm of Hg) was resolving and HEADACHE (Mild headache) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Blood pressure measurement: 180/117 mmHg (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included anti-hypertensive medicines.
Left axillary lymphadenopathy, redness and heat and mild induration at injection site.
Post vaccine admin in 30 min obs pt started coughing and feeling like she was having an allergy. Pt was sent to Med Obs. VS obtained. Pt was given water and crackers since pt haven't eaten.  pt didn't have her inhaler. PO Benadryl was offered but pt only takes at night. Pt was released and she has a b/p cuff at home to check it and follow up on her b/p. 1414 SITTING BP 170/83 HR 65 RR 18 SpO2 98% 1420 SITTING BP 156/92 HR 72 RR 20 SpO2 99% 1432 SITTING BP 155/90 HR 71 RR 18 SpO2 97%
started with a dry cough or about a week (improving), headache, sore throat off and on, fever-highest at 100, chills, shortness of breath dt congestion/coughing, body aches, sinus congestion, nasal congestion, post nasal drainage. starting 12/13/21
Patient's daughter called and explained that her mom (the patient) has been sweating, vomiting and having diarrhea which had an onset approximately 2 hours after receiving the Fluzone HD shot.  Her daughter was advised by the pharmacy team to take her to the hospital.  The daughter was called on 10/17/12 to follow up: on follow up the patient spend time in the hospital and per the daughter her mom almost had a seizure on 10/15/12 just before she was admitted.  She is out of the hospital now and is recovering.  Patient will be called within a week to make sure she has recovered.  Per the daughter the doctor determined at the hospital that her illness was likely due to the Fluzone HD since the patient was feeling fine prior to receiving the vaccine.
Patient called 2 hours later with hives and tingling in her lips. She went to the urgent care where she had IV steroids, benadryl and Pepcid. Hives had progressed and she had swelling of her upper lip. She had no respiratory symptoms. She was discharged on a Medrol Dosepak and Benadryl. She had elevated blood pressure during the medication course.
I lost my sense of smell before the booster; I lost my sense of taste before the booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ANOSMIA (I lost my sense of smell before the booster) and AGEUSIA (I lost my sense of taste before the booster) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-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 ANOSMIA (I lost my sense of smell before the booster) and AGEUSIA (I lost my sense of taste before the booster). At the time of the report, ANOSMIA (I lost my sense of smell before the booster) and AGEUSIA (I lost my sense of taste before the booster) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Company comment : This case concerns a 67-year-old male patient with no medical history, who experienced the unexpected non-serious adverse events of special interest, Anosmia and Ageusia. The events occurred on an unknown interval after receiving the second dose of mRNA-1273. The rechallenge was not applicable since events intervals are unknown. No other clinical or treatment details were given. It was reported that the outcome of the events has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.    This case was linked to MOD-2022-440979 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2022: Follow-up information included no new information.; Sender's Comments: This case concerns a 67-year-old male patient with no medical history, who experienced the unexpected non-serious adverse events of special interest, Anosmia and Ageusia. The events occurred on an unknown interval after receiving the second dose of mRNA-1273. The rechallenge was not applicable since events intervals are unknown. No other clinical or treatment details were given. It was reported that the outcome of the events has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient c/o dry throat and slight cough. No SOB nor difficulty breathing.  Scratchy throat.  Elevated BP however patient noted that it was because she was anxious. Symptoms resolved within 30 minutes and patient left the clinic.
I always have symptoms of the flu so it feels like the flu; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer) via Social media.  This case involved a patient of an unknown age and gender who always had symptoms of the flu, so it felt like the flu (Influenza like illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, it was reported that the patient always had symptoms of the flu, so it felt like the flu (Influenza like illness).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event of influenza like illness was unknown.  There will be no information available on the batch number for this case.
It was reported that a 62 year old female received Fluzone (U0933AA) in the right deltoid on 12/7/02. The pt developed a hard and hot to the touch area at the site later that day. Within 24 hrs after vaccination, the pt experienced nausea and headache the lasted for a day.
Information has been received from a nurse referring to an unspecified number of patients.  Information about concurrent condition, concomitant medication and medical history was not provided.  The nurse reported that an unknown number of doses of GARDASIL-9, (Lot # M003659 Expiration date 20-SEP-2017) experienced a temperature excursion of -4F for 4 hours 31 minutes, and an unknown number of might have been administered to an unspecified number of patients. It was unknown if any patients experienced any side effects following administration of any of the vaccines. No other information was available. This report is one of the reports from same reporter. Additional information is not expected. because no consent to contact. Sender's Comments: US-009507513-1612USA004349: US-009507513-1612USA003524.
I had my vaccination on 09/14/2022. I started to feel aches and pains on 02/15/2023. I tested COVID-19 Positive on 02/18/2023. I started to feel shaky. I contacted my physician 24-48 hours later and I was given Paxlovid. I presently feel fine on 04/05/2023.
On 5/3/02, received phone call from RN at MCC re: Pt having a reaction from vaccine. She reports that he had a fever, chills, shaking and a fine pin-point rash on his left arm which is also inflammed. He visited the ER on 5/2/02 and received Keflex and ibuprofen.
Patient received two vaccines (FLUZONE HIGH DOSE and PNEUMOVAX) on 10/19/18. Patient had no allergies listed and had tolerated vaccines in the past. Patient Questionnaire fully covered with patient. Patient developed rash under injection site just over halfway around. Rash did not itch and did not burn. Patient had no chest pain, no difficulty breathing and no wheezing. Patient still experienced some aches at injection site. Patient described having immune response including weakness, fever, pain and body aches, which were mostly resolved but last about 2-3 days. Patient thought he might have a slight middle finger tremor on left hand (same arm as injections), which is most likely not related.
lost her baby; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reported stated that the patient lost her baby.  The mother reported she became pregnant while taking bnt162b2. It was reported that the doctors said that can't prove it was from the vaccine but they say they are pretty damn sure it was because of the vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After my shot I thought I did really good. I did have soreness and sensitivity but if I touched my arm it was sore. No fever, aches, or pains. I didn't think anything of it. I've had breathing issues for 5 years and I kept telling the Doctor I cant breath and I can't mow my yard. I did a medical stress test and a nuclear imagining afterwards and I assumed everything was OK because they weren't worried about anything. I still had the problems though. 05/13/2021 after lunch my chest felt heavy and that afternoon I had a heart attack and went to ER  and it turned out that I had a blockage and the next day on 05/14/2021 Dr.  put in 2 stents. I have to carry a card now. First stents in the OM, second stent in RCA. I don't feel the shot caused this but you never know. Now I'm feeling really good.   Dose 2 Lot # could be 00821A or 008Z1A
From telephone contact received on 10/28/02, it was reported that a 78 year old male patient vaccinated with Fluzone on 10/17/02 in the left deltoid. Two days later, the patient developed a hard nodule the size of a quarter. No loss of arm use, pain, or itching occurred. The nodule is still persisting at this time. The patient was advised by his pharmacist, who administered the Fluzone, to see his physician.
Patient reported immediate redness, pain, and significant swelling around the entire circumference of her left arm from the shoulder down to the elbow within one hour of the vaccination. After initial consultation with a pharmacist that same day, she applied ice and took ibuprofen and diphenhydramine throughout the day. The next morning, she reported that the swelling improved a bit, but the arm was still red and painful and felt like "dead weight." Additionally, she reported a painful  lump in the crease of her inner elbow, about the size of a quarter raised to a height of 1/4 inch. She plans to go to Urgent Care for additional relief of the pain and swelling.
Menstruation began two weeks earlier than expected and much heavier than usual. Very heavy bleeding without signs of lessening.
There was no known specific adverse event in this situation after speaking with the patient. The patient received the Pfizer vaccine for his first dose then received the Moderna vaccine 3 weeks after for his 2nd dose.  He reported having normal symptoms such as headache and low grade fever shortly after.
No additional adverse events reported; a dose of expired PROAQUAD was administered; This spontaneous report was received from a pharmacist and refers to a 17-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-APR-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) lot # S031881, expiration date: 07-APR-2021, 0.5 milliliter (formulation, strength, frequency, route of administration were not reported) for prophylaxis. No additional adverse event was reported.
Headache; Dizzy; Fever; Nausea; This is a spontaneous report from a contactable Other HCP (patient herself).  A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via an unknown route, on 30Dec2020 at 08:45 at single dose for COVID-19 immunisation. Vaccine location was arm right. The patient was not pregnant. Relevant medical history included hypothyroidism, osteoporosis and COVID-19 (prior to vaccination). No known allergies. Relevant concomitant medications included levothyroxine and alendronate sodium (FOSAMAX). The patient was vaccinated at Workplace Clinic, age at vaccination was 57-year-old. No other vaccine was received in four weeks. Since the vaccination, the patient has not been tested for COVID-19. The patient developed nausea 20 minutes after vaccine (on 30Dec2020, at 09:05), then headache, dizzy, fever started about 2 hours after (on 30Dec2020, at 10:45). The patient was not treated for the events. The outcome from the events was unknown.
Approxamatly 12 hours after injection and after going to bed I awoke to a severe headache.  I attempted to get out of bed but realized I could not lift my head off the pillow.  I attempted to reach the phone by my bed side but found that  I was almost totally  paralyzed  neck,  both arms and shoulders to the point that I could not get out of bed to call 911 for help.  I believe I was Simi conscious on and off for approximately 8 hours.  at some point during the night I fell back asleep.  When I awoke at approximately 11:00 am I was able to get out of bed with extreme difficulty and pain in my entire body.  The symptoms took almost two weeks to go away however the headache continued for almost a month.