chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expiration date 02/28/2022, administered 04/04/2022; This case was reported by a pharmacist via sales rep and described the occurrence of expired vaccine used in a 37-year-old male patient who received HAB (Twinrix) (batch number GG3S5, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th April 2022 17:00, the patient received the 1st dose of Twinrix (intramuscular) 1 ml. On 4th April 2022, the patient started Twinrix Pre-Filled Syringe Device. On 4th April 2022 17:00, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 04-APR-2022 Reporter's comment: The pharmacist reported that, Twinrix was given to a patient after the expiry date of 28th February 2022.  The reporter consented to follow up. Additional Supportive Information: The use of Twinrix dose which was already expired on 28th February 2022, led to expired vaccine used.
My shoulder became extremely sore more like a toothache too. I was having sleepless nights due to the discomfort. I went to the ER and they gave me prednisone treatments and since then it has become a lot better. Arm movement was limited due to the pain as well. I had no other symptoms other than that. Just a week ago it was still swollen and now it is not sore to the touch anymore at least. I do have slight arthritis in that shoulder if that is need to know information.
10/20/09 Pt seen in office for recheck of URI-off antibiotics, given Pentacel-Prevnar-Seasonal Influenza vaccines. 10/22/09 Call to office this AM from mother-child not herself-very sleepy-low grade temp during night-afebrile in AM. Seen at hospital Em. Rm. Dx's ? reaction to imms. 10/23/09 Follow up office visit-resolved mental status change S/P vaccines.
I received the dose 3 of the vaccination then 3 months later I caught COVID-19 while out of town. I started to feel symptoms while on my way back into town. I felt a sore throat and heavy sneezing. On the following Monday 1/10/21 I went to get tested at Hospital. Later that day I was contacted and advised that I had tested positive for COVID-19. I didn't seek further medical attention. I just felt like I had a cold. I felt my drainage in my nasal area that would drain to my lungs. I didn't take any over the counter or prescribed medication for my symptoms. I just bed rested until my symptoms went away. It took 10 days or so for my symptoms to completely go away.
Headache, NauseaVomiting, Sweats, dysphagia Narrative:
Red, hot, puffy, pain, nausea, and flat horizontal line presenting below vaccination (FLUZONE QIV given 1 inch below PNEUMOVAX).
Fatigued; Can't balance; Can't walk; Speech disturbance; Joint discomfort; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4266705.  A 41 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: SOLUMEDROL taken for premedication, start date: 22Feb2021. The following information was reported: FATIGUE (non-serious) with onset 25Feb2021, outcome "unknown", described as "Fatigued"; BALANCE DISORDER (non-serious) with onset 25Feb2021, outcome "unknown", described as "Can't balance"; GAIT DISTURBANCE (non-serious) with onset 25Feb2021, outcome "unknown", described as "Can't walk"; SPEECH DISORDER (non-serious) with onset 25Feb2021, outcome "unknown", described as "Speech disturbance"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 25Feb2021, outcome "unknown", described as "Joint discomfort".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Excessive Salivation-Severe, Additional Details: Patient reveived vaccine at 10 AM, left store around 10:15, and noticed symptoms beginning at 10:35 upon arriving at home. Pt only called her physician after the weekend, but mentioned her symptoms were subsiding Sunday eve into Monday morning. Pt has lupus and believed this was initially at problem with her lupus, but physician office says this could have been a reaction to the vaccine
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Jul2021 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL. The following information was reported: MALAISE (non-serious) with onset 30Jul2021, outcome "recovered" (01Aug2021), described as "Within 10 min of taking it I started feeling bad"; PYREXIA (non-serious) with onset 31Jul2021, outcome "recovered" (02Aug2021), described as "fever"; CHILLS (non-serious) with onset 31Jul2021, outcome "recovered" (02Aug2021), described as "chills"; OROPHARYNGEAL PAIN (non-serious) with onset 31Jul2021, outcome "recovered" (02Aug2021), described as "sore throat"; HEADACHE (non-serious) with onset 31Jul2021, outcome "not recovered", described as "a low headache"; CONDITION AGGRAVATED (non-serious), INSOMNIA (non-serious) all with onset 31Jul2021, outcome "not recovered" and all described as "The headache never went away and got worse and worse until I was unable to sleep or anything else both times"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 31Jul2021, outcome "recovered" (02Aug2021) and all described as "pain down my arm and across my shoulder for the next 2 days". The events "within 10 min of taking it i started feeling bad", "fever", "chills", "sore throat", "a low headache", "the headache never went away and got worse and worse until i was unable to sleep or anything else both times", "pain down my arm and across my shoulder for the next 2 days", "pain down my arm and across my shoulder for the next 2 days" and "the headache never went away and got worse and worse until I was unable to sleep or anything else both times" were evaluated at the physician office visit. Therapeutic measures were taken as a result of malaise, pyrexia, chills, oropharyngeal pain, headache, condition aggravated, pain in extremity, arthralgia, insomnia. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist concerning a female patient of unknown age, who on 21-AUG-2012 was vaccinated with a dose of ZOSTAVAX 0.65 ml subcutaneously (lot # 0565AE, Exp: 23-MAR-2012 - in verification process). No other co-suspects were reported. No concomitant medications were reported. The pharmacist mentioned that a patient received ZOSTAVAX and on 22-AUG-2012 experienced injection site that was red, warm and a little swollen that was about 2 inches in diameter. No treatment was given for the events. The outcome of the events was reported as not recovered. No laboratory diagnostic studies were performed. The patient sought medical attention via visit to pharmacist. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
Moderna COVID-19 Vaccine EUA.  Friday,  Sat and Sun flu-like symptoms sore left arm pain extending into hand fever, chills, headache lethargy.  Mon May 17 above symptoms with dizziness, spinning in head, hard to think and talk, affects speech everything is fuzzy, felt like I was very drunk.  Both legs became heavy feeling and unable to move.  Went to hospital.  Transferred to hospital for neurological evaluation.  Same symptoms on Tues May 18 with some resolution later in the day.  Early in the day, a test where I was to follow a finger with my eyes only, and hold my head still, brought on the symptoms.  Wed May 19, symptoms resolved and I was discharged.  Today,  Thurs, May 20, 9:00 am, I had a 20 min episode of dizziness, spinning in head, hard to think and talk, speech was affected and I felt like I was drunk, balance was affected, but no lower leg mobility issues.  I had another episode at 11:00 am of longer duration (45 mins) but the same symptoms.
Information has been received from a consumer referring to a male patient of unknown age who was one of hist friend's sons. The patient had 5 siblings. the patient was one of the first 4 boy patients out of 6 children. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unspecified date the patient was vaccinated with M-M-R II (dose, frequency, route and lot # were not reported). The reporter reported that on unspecified date, following M-M-R II vaccinations, the patient had some minor changes in his behaviors (type of behavior changes unspecified) and within a week of vaccinations with M-M-R II, his behavior changes were very unclear and drastic and they all became less interactive and lethargic. In unknown date the patient was diagnosed with autism. The reporter stated that his friend decided not to vaccinate his two other children with M-M-R II after experienced with his 4 boys and these two children did not have autism. The outcome of autism was not reported. This case was linked with other 3 cases as they are siblings. And the cases were from the same reporter. Additional information has been requested.
Anaxiety; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via an unspecified route of administration in the left arm on 24Feb2021 at 14:00 (at the age of 69-year-old), as an single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medications included venlafaxine hydrochloride(MANUFACTURER UNKNOWN), clonazepam(MANUFACTURER UNKNOWN); all from unknown date for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration in the left arm on 04Feb2021 at 15:30 (at the age of 69-years-old), as a single dose for COVID-19 immunisation and Ceclor, and cipro on unknown date for unspecified indication and experienced a drug allergy and contrast dye on unknown dates and experienced contrast media allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 04Feb2021, the patient reported that she was led to 'vaccinator' desk for her 2nd COVID-19 vaccine, the vaccinator was complaining to her co-workers about how hot it was at her desk, that she had worked there for hours and had to move her desk. It was against a wall of windows on a warm, very sunny day the patient felt like a greenhouse! On the vaccinator desk, was a clear, not insulated case with 6-7 filled syringes of 2nd COVID-19 vaccines. The patient got her injection, and reported that whole experience projected a very lackadaisical attitude, and the vaccinator didn't even stamp her COVID-card. The patient didn't felt the relief that she imagined she would get when there was finally a COVID-19 vaccine. The patient was worried and filled with anxiety. The patient felt like her vaccine was spoiled because of how hot it was where her filled syringe sat-on top of the desk and this effected her mental health. The patient doesn't believe she was fully vaccinated and asked what can be done for her? A 3rd dose? as she didn't felt that she was fully vaccinated and still hiding in her apartment, and also stated Please contact this anxious 69 year old woman and this was unacceptable to her. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event anxiety was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
VARIVAX that underwent a temperature excursion was administered; This spontaneous report was received from a nurse referring to a patient of unknown gender and age. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported.  On 19-FEB-2021, varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, strength and route were not reported, lot # T022315 has been verified as valid, expiration date 30-JUN-2022) that underwent a temperature excursion was administered to the patient for prophylaxis (product storage error).  The vaccines administered experienced a temperature excursion of minus 10 degrees Celsius to 8 degrees Celsius (minus 3.7 degrees Celsius) for a time frame of 22 hours. There were no previous temperature excursions. Digital data logger was involved.
got Covid; got Covid; This is a spontaneous follow-up report received from Pfizer sponsored Program via a contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, first single dose and second single dose on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she got Covid for the SECOND time after she received both Pfizer vaccines. She was a nurse but wear Personal Protective Equipment (PPE) all the time. The outcome of the event was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Very severe pain: head, liver, muscular, skeleton; strong nausea, unable to eat or drink, extreme tiredness. Impossibility to do any routine activity. In bed for two plus (2+) days.
Vaccine given with immediate pain. "Hurts so bad" "I I kind of screamed when she gave it and I wasn't expecting it since nobody else seemed to have that reaction" . Patient came into office to have arm observed, Injection site appears to have been mid deltoid. She c/o pain in muscle area and above to just below shoulder . Above injection site appeared swollen, no redness.-Observed by nurse.
Headaches starting in late afternoon increasing in intensity towards evening. Feeling feverish by 8:00 PM. Took Tylenol and went to sleep. Woke up in the middle of the night with a fever of 100. Took two more Tylenol and slept until 9:00 AM. Felt fine and temperature was back to normal.
This time I predosed per allergersit recommendation with 25 mg benadryl, 300 mg pepcid, zyrtec 10 mg and acetominopehn 500 mg 2 hours prior to vaccine.  15 min in I got wheezing, thorat tightness and tongue numbness.  EMTs again called and again sats ok, BP ok and HR in 90s.  Wheezing better with 4 inhalations of Albuterol HFA. They wouldn't give me any meds without sending me to ER, so I left and went home and  took 50 mg Benadryl and another 2 sprays of albuterol at 4 hours post vaccine and did well.
Sever Headache, Fever, Congestion, Muscle ache, and chills.
Flu Immunization given in (R) deltoid 9/26/16. Pt seen in clinic on 9/27/16 with c/o swollen lymph node under arm of (R) side/chest area. Painful to touch. Voluntarily went to ER.
Case number PHEH2014US003637 is an initial spontaneous report received from a pharmacist on 21 Feb 2014. This report refers to a 62-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: not reported) intramuscularly on an unknown date. No adverse events were reported following the maladministration.
no adverse effect; administered improperly stored vaccines; This spontaneous report was received from a medical assistant  referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 28-MAY-2019, the patient was vaccinated with inadvertently administered doses of varicella virus vaccine live (Oka/Merck)(VARIVAX) that were improperly stored (Dosing details, route, frequency and indication were unknown) lot number R034394 and expiry date 27-NOV-2020 and R030614 and expiry date 23-OCT-2020 (product storage error). Concomitant therapies included sterile diluent. All lots of varicella virus vaccine live (Oka/Merck)(VARIVAX) was reconstituted with properly stored diluent. No adverse effects were reported(No adverse event). There was no previous temperature excursion. The temperature was - 10 degree Celsius and time frame was 3 hours. No further information was provided.  This is one of the three reports received from the same reporter.
Red, swollen, hot, hard skin at injection site. Gave Benadryl, Ibuprofen and Tylenol. Swelling and color decreased some. Arm was very tender, difficult for her to move much. Ice pack applied, continued medications on timed schedule. Improved after 24 hours.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 12-JAN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot#J010613, expiration date 11-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 72, unknown and R; 48, 1 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
6/12/09 - Pt presented to the emergency room for a cat bite.  Patient recieved a tetanus diptheria toxoid because hers was out of date.  6/17/09 - Pt presented to ER with numbness in her hands and feet. Numbness started on 6/16/09 with numbness in her fingers and felt "like legs were going to give out".  Symptoms worsened overnight and thus the reason for ER visit on 6/17/09.  6/17/09 - Pt diagnosed with Guillan Barre.  Physician believes Guillan Barre due to upper respiratory infection.  Husband of patient also stated pt had a "watery stool" prior to hospitalization.  Pt treated with 5 days of plasmapheresis every other day starting on 6/20/09.  Pt has improved and was discharged home on 6/29/09.  7/2/09 Hospital records received DOS 6/12/09 to 6/29/09. Assessment: Generalized weakness and numbness, likely Guillain-Barre syndrome. Patient presented with increasing tingling, upper and lower extremity numbness and weakness. Difficulty swallowing. Weakness triceps and deltoids. Unable to lift legs. Plasmapheresis. records received 7/8/09-ICD-9 codes 357.0 acute infectious polyneuritis. 518.81 respiratory failure. 599.0 urinary tract infection. 682.6 cellulitis of leg. 401.9 hyperlipidemia. 715.90 osteoarthros. 276.8 hypopotassemia. 719.7 difficulty walking. 790.29 other abnormal glucose. 276.51 dehydration.
Injection site soreness for 2 wks. Injection site looked similar to a mosquito bite (mild) in that I can see the where the needle injection was for up to a week. Soreness was limited to the injection site.
Client brought in by parents approximately an hour after receiving vaccines.  Client's left eye was swollen.  Right eye was unremarkable.  This was the only symptom that child presented with.  No labored breathing, no redness or swelling noted at injection sites.  No s/s of any anaphylaxis.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine product; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 26Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT, start date: 06Mar2021. Patient had no known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Dec2021, outcome "unknown", described as "Interchange of vaccine product"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID from 21Oct2022 to 25Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immediately after the shot,  the following happened and lasted a couple of minutes:  briefly fainted, muscle spasm, vision blurry and psychedelic, brain felt like you are high, brief uncontrollable shaking of body
ARM FELT IRRITATED, LIKE SUNBURN; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, and batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced arm felt irritated, like sunburn. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm felt irritated, like sunburn on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210530441.
I unexplainably gained 15 pounds in 2 months, struggle with extreme fatigue, very bloated abdomen and started having very erratic menstrual cycles (intermittent spotting, early menses, very late menses, painful cramps, extremely heavy bleeding, etc), migraines and eye floaters (without prior medical history of headaches), calcium levels dropped.  It has been 6 months and I am continuing to have irregular monthly cycles, abnormal difficulty losing the weight with diet and exercise and migraines.
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 13 year old male pt who experienced a sore throat and cough.  At 13 years of age, the pt received a dose on 12/15/03. Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/15/03.  Dose regimen was 0.5mL (IN).  Pt was not taking any concomitant therapy.  On 12/16/103, 1 day post-immunization, the pt experienced a sore throat and cough.  He was being treated with Tanafed.  As of 12/17/03, the symptoms persisted.  No additional information was available at the time of this report.