chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; Later at 5:00PM, I noticed that I felt on my period which is not normal because It was not the time for it; period duration was 14 days instead of 7 days; first doze at 1:00PM and noticed small rash at 2:00PM; blood pressure 160/90 and later 180/90; felt hot and cool; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EM9809, first dose) solution for injection intramuscular in the left arm on 29Jan2021 at 13:00 (at the age of 45-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical and past drug history included sulpha antibiotic allergy and allergies to azithromycin (ZITHROMAX). Concomitant medications were unknown. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated, "I got the first dose on 29Jan2021 at 1:00PM and I noticed small rash at 2:00PM. Later at 5:00PM, I noticed that I felt on my period which was not normal because It was not the time for it. It was like 2 weeks in advance of the date I should felt. In addition, my period duration was 14 days instead of 7 days which was not normal. Also, the next day after the vaccine (30Jan2021) I felt a headache in the whole left side of my face including my head. I took acetaminophen (TYLENOL) and I still with the headache. Next day I was better but I started to feel light headaches for the next two weeks and felt hot and cool in 2021. I thought I was menopause. Two days before my vaccine I checked my blood pressure and I went to the urgent care because it was high after vaccination, my blood pressure 160/90 and later 180/90 in Jan2021. I am not a high blood pressure patient." The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for high blood pressure included unspecified medication for two days. The outcome of the events was recovered in 2021. The patient was not tested for COVID post vaccination.  Follow-up (19Aug2021): Follow-up attempts are completed. No further information is expected.
After a short period, the patient then fainted; within seconds he started staring off into; This spontaneous report was received from a physician and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history.  On unknown day, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) injection (GARDASIL 9)(exact dose, dose number, lot #, expiry date, route of administration and anatomical location were not provided) for prophylaxis.  On unknown day (also reported as "about two weeks ago") within seconds after vaccination, the patient started staring off into space. After a short period, the patient then fainted. The patient was caught after he fainted and rested afterwards. The outcome of the events was reported as fully recovered with no medical treatment or hospitalization needed. No other information available at this time. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) injection (GARDASIL 9) was not applicable.  The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Tachycardia-Severe, Additional Details: Pt has vaso-vagal reaction: syncope, low blood pressure, increased pulse, profuse sweating
One week after vaccination (01/22/2021), developed red, raised rash distal to injection site. Following day (01/23/2021) rash no longer raised, but reddened area now larger than previous day and site also swollen
expired dose of TENIVAC was administered with no reported adverse event; Initial information received on 27-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 40 years old male patient who was administered expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Jan-2023, the patient received a 0.5 ml dose of expired suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT with no adverse event (frequency: once, strength: standard, expiry date: 22-Jan-2023 and lot U6922AA) via intramuscular route in the left deltoid as Immunization (expired product administered).  Action taken: not applicable.  Outcome: Unknown  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.
developed hives; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported same event for two patients.This is the second of two reports.  A 64-year-old female patient received first dose of BNT162B2via an unspecified route of administration in her arm (unknown know if right or left) on 26Mar2021 11:00 AM (Batch/Lot number and expiriaton date were not reported) as single dose for covid-19 immunisation. The patient medical history (including any illness at time of vaccination), family medical history relevant to event were none.     The patient's concomitant medications were not reported. Patient did not receive any prior vaccine within 4 weeks. In the middle of the night on 26Mar2021, patient experienced hives. Both she and her mother got BNT162B2 and both got hive. She had been taking Benadryl and the hives are ongoing. They had worsened for her. The outcome of event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) :  same reporter/event/drug, different patient
- L thigh vaccine site warm, tender, soft knot with redness. - SEPTRA 40mg/5cc - 1 1/2 tsp. Bid x 10 days.
After receiving a an injection of Prevnar the pt developed an injection site reaction with redness and hardness. The reporter stated that the reaction sometimes lasted for 3 weeks
Extreme bilateral leg weakness (proximal and distal) with multiple episodes of falls due to inability to bare weight on the legs due to the weakness.  Reported paralysis of the lower extremities for up to two minutes on multiple occasions. Had up to 6 falls due to these events leading to hospitalization.  One fall he could not get up for over 1/2 hour due to the leg weakness/paralysis as he fell between a snowblower and lawnmower and could not get his legs to work.
Patient developed a full body 'measles like' rash and causes him discomfort. He's itchy.
I got swelling under armpit; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (I got swelling under armpit) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced SWELLING (I got swelling under armpit). At the time of the report, SWELLING (I got swelling under armpit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Pt received immunization at pharmacy and they requested that we do a VAERS. Patient is here with complaints of a rash on his LEFT arm s/p SHINGRIX vaccine. He states he received the SHINGRIX vaccine approximately 2 weeks ago. He states after the injection he noticed a rash on his posterior LEFT arm from his deltoid area to his wrist. He reports the rash extended to his LEFT forearm. He denies the rash is painful. He states it is itchy. He scratched the area and a few of the papules opened and scabbed. He denies the papules drained fluid. He denies a change in soaps, lotions or detergents. He states he went to the pharmacy where he had the injection and they told him to notify his PCP. He states the rash is resolving. He continues to have an area of papules on his posterior upper arm. He has not used any OTC medications. The rash was located on his LEFT arm only.
Pt recvd vax & 2 days later devel atrophy @ inject site; 2 wks p/vax exp hypopigmentation @ inject site;
rash that started on his right forearm a couple days ago/ now spread to his left forearm.; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash that started on his right forearm a couple days ago/ now spread to his left forearm.) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash that started on his right forearm a couple days ago/ now spread to his left forearm.). The patient was treated with HYDROCORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, RASH (rash that started on his right forearm a couple days ago/ now spread to his left forearm.) was resolving.            No concomitant medications were reported. The patient had been applying hydrocortisone ointment on the rash and it seemed to be getting better.   Reporter did not allow further contact
This spontaneous report was received from a physician via a company representative referring to 3 female patients of unknown ages. Information concerning the patients' medical history, concurrent conditions and concomitant medications, was not reported. On an unknown date, the patients were vaccinated with unspecified doses of GARDASIL 9 to prevent Human Papilloma Virus (HPV) (dosage schedule, route, lot number and expiration date were not reported). On an unknown date, the patients developed severe injection site pain. The physician did not state how many doses each patient received in the GARDASIL 9 series, however the physician mentioned that the patient's injection site pain increased as subsequent doses were administered in the vaccine series. The patient's outcome was unknown.  The causal relationship between therapy with GARDASIL 9 and the severe injection site pain, was not reported.
Got covid; Got covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL3247), on 08Feb2021 as dose 2, single (Lot number: EL9269) and on 03Aug2021 as dose 3 (booster), single (Lot number: FA6780) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14Apr2022 as dose 4 (booster), single (Lot number: 005M21A) for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol; COQ10 [UBIDECARENONE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Got covid". The patient underwent the following laboratory tests and procedures: Blood cholesterol: (unspecified date) 150, notes: blood count it was over 150 his cholesterol and it worked so now it's down to 100; (unspecified date) 100, notes: blood count it was over 150 his cholesterol and it worked so now it's down to 100; SARS-CoV-2 test: (10Jul2022) Positive, notes: At home covid test, it showed up quick, it says in 15 minutes but it was not 15 minutes, the line started forming quick. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient had no Allergies. Patient had been on a statin for 30 years, it was called atorvastatin. It was just a cat. Patient started the treatment on 02July2022 and finished it on 06July2022. Patient felt great, tested negative on 07July2022 and within two days, on Sunday patient started with symptoms again. They are mild, I'm treating them like a cold. Patient have a running nose, sore throat, some drainage. Patient think it is foggy; it is starting to fade now. Additional Context: Incoming transfer from (Name withheld): INT-00708268. Patient was treating this like a cold, this was really mild, he had a runny nose, and a sore throat, but it was already now starting to fade again. Caller clarified that it was actually Saturday night 09JUL2022 when he started to feel a little wonky, so then on Sunday morning 10Jul2022, he took the covid test and it was positive. The Paxlovid itself made all symptoms go away within 2 days of starting it. He started Paxlovid on Saturday morning 02JU2022 and by start Sunday he was good, and by Monday he was symptom free. At this moment, his ongoing symptoms are his mild sore throat, slight runny nose, slight stuffiness, drainage, his symptoms are almost identical to prior Paxlovid but he has no fever, this morning it was a turn around, despite his voice being froggy, he is now taking less cold remedy this morning, he took a decongestant, but all his symptoms are improved.
Information has been received from a nurse practitioner concerning an 4 approximately 18 year old females who in approximately May 2007, were vaccinated with Gardasil. There was no concomitant medication. The all fainted after receiving the vaccine. After a while they all came to. Medical attention was sought. Additional information has been requested. Initial and follow-up information has been received from a registered nurse concerning an 18 year old female with no pertinent medical history or drug reactions/allergies who on 23-MAY-2007 "about a month ago" was vaccinated with the first dose of GARDASIL (lot# 657617/03840), IM in the left deltoid. Concomitant suspect therapy included VAQTA  (lot# 656017/1280P), IM in the right deltoid. Concomitant therapy included MENACTRA (lot #U2228AA), IM in the right deltoid. On 23-MAY-2007, the patient was given the first dose of GARDASIL vaccine and then immediately given the first dose of VAQTA. The patient fainted immediately after given the first dose of VAQTA  while sitting up. The nurse laid the patient down and she came to almost immediately. The patient was weak and very pale. The nurse laid the patient down for approximately 15 minutes while being monitored by the nurse and the patient's mother. The patient was treated with ice that was applied to her forehead and neck. Approximately 30 minutes after the event the patient was fine and walked out of the physician's office. The reporter felt that the event was related to therapy with GARDASIL. On 08-AUG2002, the patient was vaccinated with the second dose of GARDASIL (lot #655205/1426P). IM in the left deltoid. The patient did not experience any events with the second dose of GARDASIL. Additional information is not expected. Information has been received from a registered nurse concerning an approximately  18 year old female with no pertinent medical history or drug reaction/allergies who in approximately May 2007 "about a month ago" was vaccinated with the first dose of GARDASIL,  IM. The patient fainted after receiving the vaccine. After a while the patient came to and she was instructed to lay down. Medical attention was sought. The patient recovered from the event that same day. Additional information has been requested.
Janssen COVID-19 Vaccine EUA Immediate dizziness, vertigo with nausea, dry mouth, shortness of breath, headache and increased blood pressure.  Later at night I had a low grade fever with achiness and headache. The flu like symptoms resolved by morning but I continue to have vertigo and intermittent nausea and my BP was still high in the morning around 9 am but came down by 12:45 to my normal range.  Paramedics at the site did a BP, pulse ox, blood sugar, ECG . Everything was normal except my BP which was 180/90.  This morning it was 167/98 and 168/97.  No treatment.  Saw my doctor's partner at 1:00 today and BP was back to my normal range but I still have mild vertigo and intermittent nausea.  Doc gave me some exercises to do for the vertigo and did not seem to think that it was related to the shot, but since the paramedics said they had seen a LOT of the same reaction yesterday to the J&J shot and two sites in other cities shut down for the same reactions, nobody will convince me that it was anything but the shot. I expected the flu like side effects but never dreamed it would cause my  BP to spike and the vertigo.
pt recvd vax;exp malaise;several days later devel 50 to 60 vesicular lesions, mainly on trunk;
Placed follow up called on 4/5/2021 at 1:25pm: Patient reported he is still feeling warm since rcvding 2nd dose on 4/1/2021. Patient also reported on 4/4/2021 there's a sore on the outside of his mouth, and this morning 4/5/2021 the tip of his tongue is red and there is a sore inside his mouth (reporting that there's discomfort inside his mouth when he consume something hard or drink hot beverages). Patient reported on 4/1/2021 in the evening he had high fever (temp 101.9 degree) that occured through Friday morning (4/2/2021), he reported taking Tylenol one time on 4/1/2021 evening and then continued to take Tylenol 3 more times on 4/2/2021. Patient reports that his left armpit is still swollen, and has been swollen for 3 days now, there is pain if pressure is applied to the swollen area. For the swelling in the left armpit patient reported taking Aleve one time on 4/3/2021 but that did seem to help with the swelling.   Recommend patient to stay hydrated, and to take Tylenol as need for any fever or pain but not to exceed a dose of 4,000mg per day. Also recommend patient to contact PCP for further evaluation of symptoms. Patient reported will try to get in to see his PCP either 4/5/21 or 4/6/21. Advised will follow up on Wed 4/7/21 after 1pm.  Follow up on 4/7/21. Spoke with patient he stated he's feeling a lot better. Fever subsided same day after taking the tylenol. Patient saw PCP on Tuesday 4/6/21 and he was prescribed a steroid. He stated the mouth sores and armpit swelling are 80% better. Patient is overall doing and feeling a lot better. Advised to continue with the medication pcp prescribed and to call if he has any questions or concerns.
Initial report was received from a health care professional staff member on 03 October 2011. A female patient (age and date of birth not reported) had received a FLUZONE Intradermal injection (lot number, site and route of administration not reported). On an unspecified date, the patient experienced stinging immediately as the vaccine went under her skin, she noticed that her skin continued to sting and hurt to the touch. The patient also developed a lump which was getting bigger as the day went on. On Friday 30 September 2011, her whole upper arm was swollen like a "softball" and fever. The patient held ice pack as a corrected treatment. On 03 October 2011, her arm was still a little swollen and hot to the touch. No further informational was available at the time of the report. The patient outcome was not reported. Follow-up information was received from a healthcare professional on 03 January 2012. A 41-year-old female patient outcome was reported as recovered/resolved. Documents held by sender: none.
The injection site swelled within hours of adminstration. Her face turned red and hot as well.
Provider discharge summary "the patient is a 91 y/o male who presented to the ED on 1/17/2022 due to being found down at home. He was encephalopathic on arrival and noted to have a UTI for which he was started on antibiotics. He also did have rhabdomyolysis for which he was started on IVF. His symptoms did improve. He did also develop Afib with RVR and was started on metoprolol/cardizem with improvement in his HR. He did develop some fluid overload and was given diuresis with improvement. On the 25th the patient was tested for COVID due to persistent hypoxia and was found to be positive, he was started on COVID directed therapies. He completed antibiotic therapy for the UTI and encephalopathy improved. His hypoxia also improved. The patients stay was prolonged due to need to be cleared from COVID quarantine before being discharged to an SNF. His stay was also complicated by development of left sided weakness on 2/4/22 and a code stroke was called, MRI was positive for acute lacunar infarct in the posterior limb of the right internal capsule. The patients deficits quickly resolved so he was not a candidate for tPA. He was seen by neurology team who recommended ASA daily. This was discussed in depth with the patient and his family. Per family the patient has been on ASA/anticoagulants before which resulted in a GI bleed. We discussed that he is very high risk for another stroke so ASA would be beneficial for him, they continued to decline (patient and family) this medication stating they were more concerned about a GI bleed. Family and patient wanted to be discharged to assisted living facility for further care.    Patient/family verbalized understanding and agreement to the above discharge plan. All questions were answered at time of discharge"
First Covid vaccine received on 8/10/2021. Pfizer. Lot number unknown. Given intramuscular. Site unknown
Patient said within 30 minutes of receiving the vaccine her arm swelled up to a knot and her lips began tingling and swelling.  She took a claritin and started feeling better.  I recommended benadryl and to monitor symptoms and go to the er if any additional issues arose.
This spontaneous report as received from a female patient of unknown age, reporting on herself. On an unknown date in August 2014 the patient was vaccinated with ZOSTAVAX (route, dose number, dosage and lot number unknown). The patient reported that shortly after she received ZOSTAVAX, she developed pain in her arm. The patient sought medical attention (spoke with physician). The outcome of the event was reported as not recovered. Additional information is not expected because there is no contact information for the reporter.
experience a lot of something (unknown); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experience a lot of something (unknown)) 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 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experience a lot of something (unknown)). At the time of the report, VACCINATION COMPLICATION (experience a lot of something (unknown)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Approximately 20 hour post vax, the child developed a fever of 102 and complained of her leg being sore and she did not walk on it. She did walk into the clinic 4 hours later. Fever had responded to Tylenol. There was redness and slight swelling at the injection site approximately 1 1/2 inch in diameter.