chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt c/o pain immed p/vax & circumferential numbness; followed by a heavy feeling & muscle weakness later that day; following day numbness involved the entire arm shoulder;pain inj site, muscle weakness, arm heavy;
Immediate metallic taste.  Later that evening, started to feel flu-like symptoms, really sore arm, exhaustion.  Flu-like symptoms lasted several weeks.  Developed a rash from my left shoulder down past my elbow, and a swollen lump in my left arm that lasted for a week.  Had difficulty using my left arm.  Still feeling exhaustion months later, but the other symptoms have gone away.
Pt recvd 1st dose of Hep B vax & w/in 8 days of receiving vax, pt broke out in a generalized rash; presented to dermatologist & it was determined that pt should discontinue the series;
This is a spontaneous case, initially received on 11-Dec-2017 (combinedly processed with follow-up received on 15-Jan-2018), from a pharmacist and concerns a 14-year-old adolescent female patient. The patient had no medical and medication history were not reported (reported as clean health history). On 08-Dec-2017, during the preparation of the syringe for vaccination, air bubble was noticed which popped out (lost some amount of vaccine). Subsequently, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, anatomical location: right deltoid, batch no: 195232, expiry date: 31-May-2018, dose: not sure if the patient received the full dose [as reported]) (explicitly considered as incomplete dose administered). This case was associated with product technical complaint (PTC) and the corresponding reference number was 1027286. The patient did not experience any adverse events, and everything was normal. It was reported that, the patient had decided not to take second dose of flu vaccine. The reporter assessed this case as non-serious.
pt recvd vax;8dec noted swelling under rt arm & sore when arm is raised;
She got her vaccine,, and about 2 weeks later started having flutters in her calf coming up to her left thigh.  She started to feel heat from her side going up to her left arm.  Then she started to have a burning sensation in her left arm, and then my arm started to feel invisible, felt like it was not there.  She started to feel some weakness in her legs and then she had burning across her spinal area to her upper back, and burning on the left side of face and then tingling of pins and needles.  It started to come over to her right side so she started to feel the numbness in her right leg.  Then she started to feel this pain, like nerve pain in her right ankle, and it went to the side of her instep, very hot burning sensation in the right ankle, instep of the right ankle.  Then she started to have pain on both ankles, the top of them.  It felt like nerve pain, in a particular area.  She constantly has burning in her left thigh, and she had suffered for about 5 weeks terrible brain fog of confusion, was scratching all over her body, had hives.  She had severe fatigue, was laying down and did not want to get up.    She is still having burning sensation in her ankles, thighs and back.  She has not felt it in her face in the past three days, and the brain fog is not as bad as it was.  She still gets random spasms all over her body, she is feeling it in her right arm, sometimes in her back and in her stomach (unusual pain).  Like not like a stomachache, but a pain that she cannot describe properly that was not there before the vaccine.    She has had several tests done, she has the reports with her.    The lower back pain is very tight in the morning, tight and stiff.
Client felt some dizziness and light-headedness after getting vaccination, while being monitored afterward. Patient drank some water and was given juice. Vital signs were taken (below). Patient refused a call to EMTs onsite. Onside MD did an assessment. Client states a history of this type of reaction to other vaccines and blood draws. Client refused another set of vital signs. Client left the facility under own volition, reporting feeling better.
Shot in left shoulder - within hours numbness in left side cheek - up to eye - left side of lips - left edge of tongue.
Vaccine administered at 2pm. 1/8/21 @ ~ 4pm  LEFT arm soreness (which persisted all evening) 1/9/21 @ ~ 1am  I awoke from sleep with worsening LEFT Arm soreness, headache (bad) and body aches 1/9/21 @ ~ 11am Feeling more fatigued, chills, low grade fever 99.9 1/9/21 @ ~ 2 pm, continue to have body aches, fatigue, itchy nose/post nasal drip, chills fever 100.7 1/9/21 @ 8pm continued w/ prior symptoms, developed mild cough ( at this point I felt symptoms may be outside vaccine side effects, honestly wasn't sure if it was seasonal allergies w/ vaccine side effects) 1/10/21 ~ 10 am Awoke feeling better, remained fatigued and with mild intermittent cough but body aches/headaches resolved, opted to go for testing 1/12/21 informed of Covid + test (PCR), was advised by my hospital employee health to complete this form It should be noted I underwent mandated employee testing on 1/5/21 which was negative.
she developed shingles; never got the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 6 weeks after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: she developed shingles) and incomplete course of vaccination (Verbatim: never got the 2nd dose). The outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 17-AUG-2023 The pharmacist reported that patient received 1st dose of Shingrix in the beginning 2020 but never got the 2nd dose. 6 weeks back she developed shingles but not active? Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case was found as duplicate of case US2023112146. All the information from the case US2023112146 was merged into this case. The case US2023112146 was deleted and this case stand as case of record for this patient. The reporter consented to follow up.
heart was racing / heart palpitations; felt off; This case was reported by a consumer via call center representative and described the occurrence of palpitations in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number N549A, expiry date unknown) for prophylaxis.   Previously administered products included flu vaccine (had in past and did not had these reactions). Concurrent medical conditions included atrial fibrillation. Concomitant products included lisinopril and metoprolol.   On 21st October 2020, the patient received Fluarix Quadrivalent 2020-2021 season (intramuscular). On 21st October 2020, less than an hour after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced palpitations and feeling unwell. On an unknown date, the outcome of the palpitations and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the palpitations and feeling unwell to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient received Fluarix vaccine and 1 to 2 minutes after receiving the vaccine she felt off, heart was racing, and had heart palpitations. The patient reported these events lasted about 3 minutes and resolved completely within an hour. The reporter did not consent to follow up. The reporter did not have expiration date information for the vaccine given and did not have HCP information to provide for follow up.
bad headache; feeling like falling; skin feeling cold; heart palpitations; tingling hands and feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Oct2023, outcome "unknown", described as "bad headache"; VERTIGO (non-serious) with onset Oct2023, outcome "unknown", described as "feeling like falling"; PALPITATIONS (non-serious) with onset Oct2023, outcome "unknown", described as "heart palpitations"; FEELING COLD (non-serious) with onset Oct2023, outcome "unknown", described as "skin feeling cold"; PARAESTHESIA (non-serious) with onset Oct2023, outcome "unknown", described as "tingling hands and feet".  Additional information: The reporter wanted to know how long did side effects last.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300334595 same reporter/drug, different patient/AE.;US-PFIZER INC-202300334599 same reporter/drug, different patient/AE.;
Patients arm was warm to touch, had hives, but they were not itchy.  Patient was given BENADRYL.
A good friend who got the Shingles shot and she got the Shingles/Suspected vaccination failure; A good friend who got the Shingles shot and she got the Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of Suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported.  The patient was reporter's good friend. The patient got Shingles after Shingles shot. The reporter stated it was not good for patient and was terrible. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
The injection was painful immediately after injection. I was hopeful the pain would lessen as it usually does after an injection. Unfortunately it did not.  The pain has continued and in fact worsened.
Eighteen days after receiving the shot, I noticed a large, red blotch area around the vaccination site on my left arm.
Partial dose of vaccine (less than 1/2 dose) was given in error adn repeat dose has been rescheduled per CDC Guidelines.  No adverse event per patient. Patient will return to facility next week for revaccination.
urinary retention, hypertensive urgency, went to ER and was told it was probably not related to the vaccine.
Following day (Wed) my right eye was irritated and became itchy later on.  Had Dr look at it and she started me on hot compresses with orders to start eye drops with antihistamine if this did not help.  Did hot compresses felt a bit better on Thurs.  Fri eyes were worse, started Eye drops.  Saturday ears were itchy and sore with drainage--thought infected.  Sunday both eyes were red, itchy oozing,, ears still oozing and sore--went to Urgent care.  They said no ear infection and started me on Eye drops with steroids but could not get them until Monday around 5pm.  Corners of mouth started cracking open as well.  Monday started steroid drops. Wednesday eyes were much worse and felt like glass in them.  called Dr.  She said to stop steroid drops and go back to antihistamine drops and start Claritin.  Started immediately and I started putting Ivarest in my ears. Eyes have stopped oozing but are still red.  Ears are clearing up and not as sore.  Mouth is starting to clear up
Initial and follow up information has been received, via the manufacturer pregnancy registry, from a registered nurse, and a 25 year old female with a history of one previous full term delivery with no complications (date unspecified), who on 09-FEB-2007, was vaccinated with a first dose of Gardasil (Lot #654741/0013U). There was no concomitant medication. On 16-APR-2007, the patient reported that she was "four or five weeks pregnant." The date of the LMP and estimated date of delivery were not provided. Follow up information received from a registered nurse, indicated that the patient was taking prenatal vitamins (PRENATAL ELITE), and had experienced bleeding during her pregnancy. On 26-APR-2007, an ultrasound confirmed the presence of a yolk sac, but a fetal heart sound or fetal motion was not detected. On 29-APR-2007, the patient was diagnosed with a urinary tract infection and was treated with MACROBID 100mg, twice daily, from 29-APR-2007 through 03-MAY-2007. During this time, an human chorionic gonadotroin test (HCG) test result confirmed an "abnormal rise" in the value (date not specified). On 04-MAY-2007, a repeat ultrasound confirmed the previous finding of yolk sac, but no detection of a fetal heart sound or fetal motion. a dilatation and curettage (D&C) was performed, and the products of conception was examined (results not specified). At the time of this report, it was unknown if the patient had recovered. Upon internal review, no fetal heart rate (resulting in a D&C) was determined to be an other important medical event. Additional information has been requested.
10 min after shot given donor became dizzy and had blurred vision. Donor laid on bed and legs elevated cool clothe and juice given.
This spontaneous report was received from a nurse and refers to a 12 year old female patient. No information concerning the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 08-JUL-2016, the patient received the first dose of GARDASIL ( 0. ml, subcutaneously (lot # M009362 and expiration 13-JUN-2018) in her right thigh. On the same day, she was given HAVRIX (lot#C9d2, expiration date: 05-MAY-2018) (dose, frequency and route of administration not provided) in her arm and MENVEO (lot# A15123, expiration date: 30-MAY-2017) (dose, frequency and route of administration not provided). On 11-AUG-2016, the patient was seen for a lump in the right thigh swelling and redness. the subject received treatment. Lump was still present but much smaller in size. No further information was given. the outcome of the events was unknown. the relatedness between the event and vaccinations was not provided. Additional information has been requested.
10 minutes after injection patient experienced lightheadedness and nearly fainted. Water and ice packs were provided, candy was offered in case of low blood sugar but declined, ambulatory care was offered and declined. After about 30 minutes patient was well enough to leave on their own power.
On Monday 12/12 my husband woke up sick and got a PCR as we waited for results, he ran a fever I had nothing. I started having lots of cough and congestion and his test came back positive which made me test. I tested positive for COVID-19. Throughout the day my symptoms got worse, so we called the MD and they prescribed PAXLOVID on 12/14. Took the medication at 3PM and then again at 11PM. Since then, I have been taking it in the morning and all symptoms have gotten better. Still have the cough congestion but it seems like I am getting a sinus infection. The fatigue is bad along brain fog.
This spontaneous report as received from a physician via Pfizer (Mfr control # 2015038893) refers to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On 08-DEC-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 dose, route, lot# and expiration date were not reported. On an unknown date, the patient experienced dizziness, chronic abdominal pain, headache, terrible gastritis, flu, tiredness, loss of appetite and her arm was really really sore, it hardly reached up. The outcome of the events was not reported. The relatedness between the events: dizziness, headache, terrible gastritis, flu, tiredness, loss of appetite and 'her arm was really reallly sore, it hardly reached up' and PNEUMOVAX 23. The patient considered chronic abdominal pain to be not related to PNEUMOVAX 23. Additional information is not expected, because the reporter did not wish to be contacted.
Stiff neck, couldn't move around day 2&3; Sore throat; having trouble swallowing without pain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number. ER8727), via an unspecified route of administration in the left arm on 22Mar2021 at 09:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Prior to 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 medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Mar2021 at 09:00, the patient had stiff neck, couldn't move around day 2 and 3. The patient had sore throat and was having trouble swallowing without pain. The patient also experienced fatigue. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events stiff neck, couldn't move around day 2 and 3, sore throat, having trouble swallowing without pain and fatigue. The clinical outcomes of the events stiff neck, couldn't move around day 2 and 3, sore throat, having trouble swallowing without pain and fatigue were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
LEFT SHOULDER BURNS AND ACHES LIKE NERVE WAS DAMAGED.  NO TREATMENT.
Arm that the injection was given as well as the other arm are aching/sore as if vaccine was given in both arms.
Red patches - started night of flu shot. Radiated in axillary area where shot given. Feel feverish in affected area.
Booster; Mild injection site pain (started date of booster dose); headache; muscle/joint aches; muscle/joint aches; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Dec2021 10:30 (Lot number: FH8027) at the age of 52 years as dose 3(booster)single for covid-19 immunisation. Relevant medical history included: "Oysters" (unspecified if ongoing). Concomitant medication(s) included: SHINGRIX, administration date 02Dec2021. Vaccination history included: Pfizer (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 02:15 PM, Route of Administration: Intramuscular), administration date: 01Apr2021, when the patient was 51 years old, for Covid-19 immunization; Pfizer (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 11Mar2021, when the patient was 51 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 17:00, outcome "recovering", described as "Booster"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2021 17:00, outcome "recovering", described as "Mild injection site pain (started date of booster dose)"; HEADACHE (non-serious) with onset 20Dec2021 17:00, outcome "recovering", described as "headache"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 20Dec2021 17:00, outcome "recovering" and all described as "muscle/joint aches"; CHILLS (non-serious) with onset 20Dec2021 17:00, outcome "recovering", described as "chills". Therapeutic measures were not taken as a result of immunisation.  Follow-up attempts are completed. No further information is expected.
Pain and swelling of upper arm increased over 2 days-was approx. 3 by 1.5 in., then decreased over next 5 days.  Headache started 1st evening and continued for 2 days. Body aches started first night and increased over 2 days. Could not sleep 2nd night because of all these symptoms. Started Tylenol, first dose 24 hours after shot, second and third doses next day. Relieved headache and body aches. Started with a sore throat and swollen glands a week after dose, continuing now for 3 days.
covid vaccine breakthrough case  dose 1 Moderna  2/27/21  025A21A dose 2 Moderna  3/23/21  045A21A
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Patient about 12-24 hours after shot started to develop a rash on arms/neck and hands. Her arms/hands started to swell and she developed blisters in the mouth and had blisters on her hands and neck as well. She had itching all over her arms and hands and swelling of the arms and hands too. She also felt a warming/hot and burning sensation in her arms and hands too. She has been putting clobetasol and hydrocortisone cream/ointment and Levicyn (compound by Dr.) on the blisters and rash.
SIDS on 8/18/01. No previous illness. Entirely healthy and normal child. Found dead by childcare personnel. Autopsy reports cause of death as SIDS
Arm still sensitive; Initial information received on 19-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves adult patient (unknown age and gender) patient who had arm still sensitive (pain in extremity), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment, vaccination, concomitant medication 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: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious arm still sensitive (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Nausea, vomiting, Fatigue, headache, muscle pain, chills , lack of appetite -drank only water until 2-6. excessive sleeping.(day and a half).  No treatment- After vomiting about 36 hours after vaccine, felt better. No fever
pt recvd vax 31JAN95;MD visit 3FEB95 parent reported a rash around inj site since vax;on exam, pt had red (not uniform) rash (small medium size papules); 9cm x 6cm surrounding inj site w/local swelling & tenderness;no fever;
Large 2 inch red welt at injection site that is causing pain into my armpit. Body aches and chills, mild headache and trouble sleeping night of injection