chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Raised itchy Rash on right breast and neck and chest; itchy Rash on right breast and neck and chest; This is a spontaneous report received from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8732) via an unspecified route of administration in the arm right on 27Mar2021 at 13:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included birth control.  The concomitant medications included ethinylestradiol, norgestrel (CRYSELLE) indicated for birth control since an unspecified date. Allergic history to medications, food, or other products was reported as not known. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. On 29Mar2021 at 00:00, the patient experienced raised itchy rash on right breast and neck and chest. The clinical outcome of the event raised rash, itchy rash on right breast and neck and chest was not recovered at the time of report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I received the shot at 2:50, at about 5pm I had a bad headache and I noticed my left ear was hot. By 6pm I noticed my ear was extremely red and swollen.
25min - achy tingling L arm/hand sensitive skin @ L collar bone day 1 - body aches very tired day 2  -  body aches very tired sensitive skin @ L collar bone 99.6F fever (101.2 @ collar bone) shortness of breath, increased blood sugar day 3 - extremely tired lump @  L collar bone, sensitive L arm pit, body aches reduced, increased blood sugar day 4 - Very Dizzy, increased blood sugar, joints tight
on 2/27/21 I experienced fatigue and body aches, as well as sore injection site.   on 3/1/21 I felt fine during the day but at 9 PM I experienced severe dizziness and fatigue.  My blood pressure went to 168/85. on 3/2/21 I felt better, BP was 126/64 at 9 AM.  Still fatigued and an upset stomach.  Foggy in the head and still fatigued.
Shortness of breath-clogged head and upper chest-O2 level went to 82 with severe cough and fever. Had to go to ER and spent night at hospital and got sent home with Oxygen that a company delivered and 9 day anti viral medication.
Moderate pain, redness and swelling of left tricep area, unable to touch.  Fever of 100 degrees, headache, nausea, fatigue, All have occurred since midnight.
Patient underwent palliative tracheostomy surgery 1/18 due to airway obstruction secondary to laryngeal cancer.  Was diagnosed with COVID 3 days PTA by testing at wife's workplace ~1/15, admitted for acute respiratory failure with hypoxia secondary to COVID.  He developed neutropenic fevers 1/19, possibly due to COVID, aspiration pneumonia, or other cause.  One dose filgrastim given with improvement of white blood cell count.  He initially required only humidified air by trach dome, then developed hypoxemia 1/21. Treated with a 10 day course of dexamethasone, symptoms improved. Discharged home on 2/2/22. Hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous report was received from a medical assistant and refers to a 6 months old patient of unknown gender. No information about the patient's medical history and concurrent conditions was provided. On 16-OCT-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M044397 with an expiration date in 20-JUN-2018), for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown), that underwent a temperature excursion from 9 degrees Celsius to 25 degrees Celsius during 20 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1801USA001565: US-009507513-1801USA001566: US-009507513-1801USA001567: US-009507513-1801USA001569: US-009507513-1801USA001570: US-009507513-1801USA001571: US-009507513-1801USA001572: US-009507513-1712USA003377:
She came into our pharmacy today (05/01/2023) complaining of pain in her left shoulder. She said it developed several days after administration of Shingrix on February 1, 2023. It got progressively worse. She says she is in a lot of pain and can no longer raise her left arm. We notified her physician's office. They will be contacting her.
felt kind of achy in her arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Lot number: ER8733) at the age of 76 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing); JANUVIA [SITAGLIPTIN PHOSPHATE] taken for diabetes mellitus (ongoing); INDAPAMIDE taken for hypertension (ongoing); LISINOPRIL taken for hypertension (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "felt kind of achy in her arms". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Patient received flu shot 1/8/17 - on Monday 1/9/17 patient noticed itching on back. Tuesday 1/10/17 patient saw red rash on chest and back-with raised red bumps. Area of involvement is being treated with steroid cream.
Chills; severe diarrhea for 3 days; no appetite; fever of 100.7 for two days; neck pain; joint pain; migraine; severe fatigue/Exhaustion; increased sense of smell; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 01Mar2021 13:15 (Lot Number: EL9262) (at the age of 61-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension. Concomitant medications within two weeks of vaccination included venlafaxine hydrochloride (EFFEXOR); losartan potassium (LOSARTIN); both taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfur and experienced drug hypersensitivity, cipro [ciprofloxacin] and experienced drug hypersensitivity, iodine and experienced drug hypersensitivity. The patient did not receive any other vaccine within four weeks of vaccination. The patient did not have covid prior vaccination and was not tested for covid post vaccination. On 05Mar2021 19:00, the patient experienced chills, severe diarrhea for 3 days, no appetite, fever of 100.7 for two days, neck pain, joint pain, migraine, severe fatigue, increased sense of smell, exhaustion. The patient did not receive any treatment for the events. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Rotarix mixed with saline water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Rota (Rotarix lyophilized formulation) (batch number 7L2D7) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced wrong solution used in drug reconstitution (Verbatim: Rotarix mixed with saline water).         The outcome of the wrong solution used in drug reconstitution 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 Information: GSK receipt date: 7-Mar-2023 The reporter told that it was not clear the date or to whom this vaccine was administered.  The reporter told that after doing the facility's inventory it was discovered that there was more diluent than powder component, leading to the conclusion that maybe one dose was reconstituted with an inadequate diluent. The reporter consented to follow-up. The patient received a dose of Rotarix which was reconstituted with saline water, which led to wrong solution used in drug reconstitution.
Patient experiencing tingling lips, lump in throat, and left arm numbness.  Reports worsening over wait period. Provider notified. Escorted to ER.
This case was reported by a consumer and described the occurrence of rash in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on a unknown date, had no appreciable reactions to the first shot). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. About a day after vaccination the patient developed a severe rash in my groin, down the insides of his thighs and all over his hands. The reporter reported is this typical and wanted to know can you have a first shot with no reaction and a second shot causing a severe reaction. The reporter wanted to know was the first shot not administered correctly or does this occasionally happen.
Induration, neuropathy on head, back, arms, legs  Spikevax-12 + covid 23-34 pfs
covid vaccine breakthrough case  dose 1 2/18/21  Moderna  013M20A dose 2 3/18/21  Moderna  030A21A dose 3 10/28/21  Moderna  014F21A
did not feel well from other doses; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel well from other doses) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (did not feel well from other doses). At the time of the report, MALAISE (did not feel well from other doses) outcome was unknown. Concomitant medication information was not provided by the reporter. She did not had any problem with the first dose. Treatment information was not provided by the reporter.   This case was linked to MOD-2022-542593 (Patient Link).
Heart attack; Fever; Chills; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 11-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Severe headache). On 14-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown and PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Severe headache) was resolving.            Concomitant product use was not provided by the reporter.   The patient forced himself to his place of employment for work on Tuesday 13Apr2021 and left work around 2PM. By that afternoon he felt terrible. He went to bed and woke up around 4am Wednesday 14Apr2021 with severe chest pain where he was rushed to the emergency room. Then they confirmed the patient had a heart-attack with no other offending agent besides the vaccine. It was not confirmed if the patient is on any other medication regularly.   Treatment medications included Tylenol and Motrin alternating for fever, chills and headache.  Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
The child developed fever of 106F, no seizing. Seen in ER. Fever persisted despite use of Tylenol and Motrin. Admitted 4/19/99 and 4/20/99. Fever aborted after 7 days. Child has been dx'd as autistic. Vaxs are up to date and has received DT only, since 8 weeks w/other vax. The annual follow-up states that the pt's brain is damaged for life.
I am having chills since last night; Shortness and breathlessness last night; throat is super dry; don't have too much pain in my left arm right where I got the vaccine; Left clavicle that is swollen and painful to touch; Left clavicle that is swollen and painful to touch; Little bit fever; This is a spontaneous report from a contactable consumer reported for herself. A 29-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (expiry date: Apr2021), via an unspecified route of administration in left arm on 05Jan2021 at single dose to get vaccinated to prevent COVID. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and hadn't taken Vitamins yesterday or day before. The patient got yesterday on 05Jan2021 the vaccine and thought that it was a side effect which she didn't have with the first vaccine. She had been having chills since last night 05Jan2021 and little bit of fever in Jan2021. She didn't have too much pain in her left arm right where she got the vaccine but her left clavicle that was swollen and painful to touch in Jan2021. The patient felt like she had a little bit of shortness and breathlessness last night 05Jan2021 but she was fine, her throat was super dry in Jan2021. For lot number, she stated "It is E. I am not sure what the next one is. It might be like a 21284." The patient had taken only pain killers she took two pain killers before she went to bed she took two pain killers when she woke in the middle of night and in morning. For Lab work, she just started feeling like between 12. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
A 61-year-old female received a Td vaccine 04/30/1. In November 2011, during a routine health screen at a pharmacy, the patient reported to the pharmacist that she experienced a rash at her jaw line and on her chest after receiving a Td vaccine. The patient had recovered from the rash, but indicated that she has not felt healthy since. MBL is not able to obtain additional information regarding the patient's status.
Patient received the vaccine. Patient got up, took a picture of the form she filled out with her phone to print out for school. Patient and her mother went to another isle in the pharmacy. After about 2 minutes, the pharmacy staff noticed that she was sitting on the ground holding her head. She stated that she felt funny, dizzy and about to pass out. We moved her to the pharmacy shot booth where she had about a 20-30 second seizure. We contacted EMS during this time.
5 days after my first dose, I woke up with red Itchy bug bite-like bumps in random parts all over my body. Some areas are a group of bumps, some areas are just 1 or 2. I continued to develop more of these red bumps since they first appeared.
Pt received the BOOSTRIX vaccine in the left arm, then pt switched chairs so that I could give him the flu shot in the right arm, about 30 seconds after sitting down I had wiped his arm with alcohol and picked up the flu shot and pt informed me he felt dizzy and tired then he tilted his head to the left and seemed to go unconscious, his head fell backwards and I grabbed his head and neck to support him and avoid him from hitting his head, I kept asking him if he was alright and if he was ok, I checked his pulse and he had a pulse and was breathing, then his neck went completely rigid, he sat up and starting shaking as if he was seizing, I told my technician to call 911 immediately, he seemed to come to and asked to lay down, I grabbed his jacket and my jacket and put it under his head and elevated both feet on a chair for him. I told my technician to grab the blood pressure cuff for me and to take his pulse. He was conscious and talking at this time but still very woozy and nauseous. The paramedics arrived at this point while I was just squeezing the blood pressure cuff. Pt informed me that he was jetlagged and had low blood sugar. He at this point told me of the previous fainting episodes.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 03-JUN-2010, the patient received improperly stored VARIVAX dose 2, from lot # 665413/1128Y, expiry date 07-AUG-2011 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Patient complained of pain in left thigh after the vaccine. The day after the vaccine there was swelling, tenderness, and splotchy macular erythema on the left anterior thigh extending to left knee. He had temp of 100.6 and vomited twice on 04/7/2010 prior to exam.
Information has been received from a physician concerning an 18 year old female who on 16-JUL-2009 was vaccinated intramuscularly with first 0.5mL dose of GARDASIL (Lot number 659054/0315Y) in the left deltoid. It was noted that "the patient might have been taking SPRINTEC". Within 48 hours after vaccination, on 18-JUL-2009, the patient "experienced diffuse body itching with no rash". The patient sought unspecified medical attention. Follow up information has been received from the physician concerning the patient with egg and plant allergy and with no illness at time of vaccination who on 18-JUL-2009 experienced itching and developed pustular rash after scratching. Subsequently, the patient recovered. This is a consolidation of two reports concerning the same patient. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received bnt162b2 (BNT162B2), in Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2023) Unknown results, notes: Strong covid test indication. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Information has been received from a pharmacist concerning a 64 year old male patient with hyperlipidaemia, hypertension, asthma, eczema and coronary artery disease who on 10-DEC-2007 was vaccinated with a dose of ZOSTAVAX (dose and frequency unknown). On 14-DEC-2007, the patient experienced a shingles like rash on the upper right hand quadrant of his torso and was seen by his physician. The patient's outcome was unknown. There was no quality complaint. Additional information has been requested.
Muscle pain; fatigue; Headache; diarrhea; Fever 101.5; This is a spontaneous report from a non-contactable pharmacist reporting for himself. A 42-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 20Jan2021 02:00 PM at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm at 42 years old on Dec2020 03:00 PM for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient experienced muscle pain, fatigue, headache, diarrhea, fever 101.5; all on 20Jan2021 06:00 PM. The patient required 12 hours in bed to recover. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had Covid test post_vaccination (Nasal Swab,Bi naxNow) on 23Jan2021 with negative result. Outcome of the events was recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
She got the vaccine, she broke into a horrific rash in-between the cheeks of her rear-end the next day following the vaccine when she woke up.   The welts were hard as rocks, and had the pin point whitehead peaks on them, just above the anus in the crack area.   She did have shingles vaccine about 3 months prior to this vaccine, and felt like possibly she had shingles.  She also  had a sinus infection in 11/18/20, the flu shot, pneumonia and Shingrix vaccine and tetanus shot was on 10/27/20, then the booster for shingles on  1/7/21.   The rash was very itchy.  She started treating that with Benadryl cream and diaper rash, Sitz baths to get rid of the pain.  The following day they had flattened out but still hard as rocks.   The rash now is painful, but able to sit down, the white heads are gone, but is still painful blistery, achy.   Her mother has had shingles and feels that it may be some type of shingles.  She also felt some dizziness that went away a day later.