chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing), notes: other medical history: RA; "Panuveitis" (unspecified if ongoing); "GAD" (unspecified if ongoing), notes: Other medical history: GAD; "Depression" (unspecified if ongoing). Concomitant medication(s) included: INFLECTRA [INFLIXIMAB]; CELEXA [CELECOXIB]. Past drug history included: Clindamycin, reaction(s): "Known allergies: Clindamycin", notes: Known allergies: Clindamycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on possible temporal association the causal association of suspect drug BNT162b2 and for reported events- Drug Ineffective and COVID-19 cannot be excluded .
Pt was accidentally given a 3rd dose of Flu vaccine for this season. Parents notified Dr of the mistake the next day, medical assistants were unaware of the mistake the day it occurred. Dr  counseled parents stating that the extra dose was safe for the patient and they may have a mild or normal vaccine response. Further investigation at beginning of the next week showed that miscommunication led to the extra dose being given. The manufacturer was contacted and parents were notified that the manufacturer had no other concerns to add. Mom stated that patient did not have any adverse reaction in the days following the vaccination.
This case was reported by a other health professional and described the occurrence of accidental overdose in a 21-month-old female patient who received FLULAVAL QUADRIVALENT (batch number 2G3J4, expiry date 30th June 2015). On 24th November 2014, the patient received FLULAVAL QUADRIVALENT .5 ml. On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown. Additional information: A 21 month old pediatric patient was accidentally given an adult dose of flu vaccine.
Patient stated she had received a MMR vaccine and later that night her jaw appeared swollen and painful. She stated that she felt feverish. She came to student health services 2 days after receiving the MMR with left sided facial swelling near jaw line, no erythema, no warmth and non tender at the time of the visit. Instructed to use Ibuprofen 600 mg 3 times daily.
I had muscle aches, diarrhea,  extreme tiredness (not sleeping well) for 3 days after the shot. Then I was just tired all the time (continued not sleeping well) and experiencing diarrhea this lasted for 2 and half weeks. At this time I am still experiencing tiredness and not sleeping well. However the diarrhea seems to have  resolved.
Dose 1 : sep 5th 2019 and Dose 2: nov 10 2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number CE45H, expiry date 1st October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 5th September 2019).   On 10th November 2020, the patient received the 2nd dose of Shingrix. On 10th November 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows : The patient received the 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. There was a possibility of 3rd dose to be administered to patient but it was not confirmed as there were no other details about the vaccine was reported. The reporter consented to follow up.
Aches, fever, diarrhea, pain at injection site.  One week after testing a large red welt appeared at the injection site that is warm to the touch.
Anxiety, cold, tachycardic. Placed in supine position by EMTs (remained on-site). All symptoms resolved.
Cutaneous vasculitis; thrombocytopenia; Initial information received on 22-Feb-2023 by health care professional from regarding an unsolicited valid serious case issued from a literature article:   This case is linked to cases 2023SA063143, 2023SA063145, 2023SA063146, 2023SA063147, 2023SA063137 and 2023SA063148 (CLUSTERS).  This case involves a 75 years old male patient who experienced cutaneous vasculitis and thrombocytopenia while receiving vaccines MODERNA COVID-19 (coronavirus 2019) VACCINE and INFLUENZA VACCINE (QUADRIVALENT).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect MODERNA COVID-19 VACCINE not produced lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious cutaneous vasculitis and thrombocytopenia (latency: 6 days).  These events were assessed as medically significant.  Action taken with QUADRIVALENT INFLUENZA VACCINE (INFLUENZA VACCINE (QUADRIVALENT)) and ELASOMERAN (MODERNA COVID-19 VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (Cutaneous vasculitis, thrombocytopenia).  At time of reporting, the outcome was Unknown for the event cutaneous vasculitis and was Unknown for the event thrombocytopenia. Reporter's causality: Related; Sender's Comments: Sanofi company comment dated 27-FEB-2023: This case involves a 75 years old male patient who experienced cutaneous vasculitis and thrombocytopenia while receiving vaccine INFLUENZA VACCINE (QUADRIVALENT). Based on information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed.
approx 4 to 5hrs p/vax itching noted-on exam hives noted-legs, feet, arms, lower abd (initially itching @ site of inj which passed p/1 1/2 to 2hrs);rash cont x 5 days;reported to family MD 10NOV95;Pred for relief then recovered;
Short (<1min) generalized seizure followed by a 5 minute postictal state (drowsy, incontinent of urine). Seen in UCC where labs were all normal. No fever. Back to baseline. No treatment given. EEG ordered for future given past hx of ? seizure.
Pt recv vax on 3/18/99; 5 min post vax pt fainted, exp pale skin color, hot body
1st dose Sep 2021, 2nd 13Oct2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose (0.5ml) received in September 2019 intramuscularly into unknown arm).   On 13th October 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's comment: The patient self-reported this case. The patient received her second Shingrix vaccine into unknown arm on 13th October 2022 (inappropriate schedule of vaccine).  The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Shingrix vaccine later than the recommended interval, which led to lengthening of vaccination schedule.
Numerous grand mal seizures, never before experienced,, including 2 instances of status epilepticus. Have had epilepsy since 2012 and current medication levels are in normal range.; Numerous grand mal seizures, never before experienced,, including 2 instances of status epilepticus. Have had epilepsy since 2012 and current medication levels are in normal range.; This is a spontaneous report from a contactable consumer reporting for self.   A 29-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 19Apr2021 at 13:30 (Batch/Lot number was not reported) as single dose (at the age of 29 years old) for COVID-19 immunization.  There was no other vaccination received in the 4 weeks prior. Medical history included epilepsy since 2012, autism spectrum disorder, respiratory illness in Nov2019 (not caused by the flu but with COVID-like symptoms), high blood cell count (previous treatment). There were no known allergies. Concomitant medication(s) included lamotrigine (LAMICTAL) and escitalopram oxalate (LEXAPRO), both taken for epilepsy, start and stop date were not reported.  On 25Apr2021 at 20:30, the patient experienced numerous grand mal seizures, never before experienced, including 2 instances of status epilepticus. The patient has had epilepsy since 2012 and current medication levels were in normal range. There was no treatment received for the adverse event. The events resulted in a Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19.  The outcome of the events grand mal seizures and status epilepticus was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Still feel something; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a 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 feeling abnormal. On an unknown date, the outcome of the feeling abnormal was not recovered/not resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK receipt date :12 Jan 2023 Reporters comment: This case was reported by a consumer via interactive digital media. The patient reported that was going through same thing was vaccinated for more than 2 years and still felt something.
Symptoms appeared 8 hours after vaccine administration of chills and fever of 100.2 F.  Next day had headache, feeling tired.
Right arm local reaction, slight swelling, redness, and warm to touch. Patient's parent was advised to return to clinic if any problems and to ice the area as needed, and also to take Ibuprofen.
I felt a pea-size lump on my left groin (mons pubis) and by February 2nd it grew to the size of a walnut; feeling dense and thick. I went to the doctors who felt it was a staph infection. I took anitbiotics for 10days 4x/day. I had one severe like this in 1987 after gall bladder surgery on my inner knee. Nothing so extreme before.
Administered with an expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine). On 25-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information was reported by reporter.
On 6/13/2004 child developed tonic-clonic seizure activity lasting >30min-stopped after ED administration of lorazepam. Prolonged, continued body posturing leading to Phenobarbital administration, paralysis, intubation and Mercy flight transfer to strong Hosp.
This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 03-year-old, child of unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour off and on for 2 weeks. On 07-Feb-2018, the patient was administered with FLUCELVAX QIV (dose, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195236, expiry date: 31-May-2018) that was stored out of recommended temperature for an unknown indication. No adverse event was reported. Non-significant follow-up received from the reporter on 07-May-2018: The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
pt recv flu & pneumococcal vax combined & given in one inj & exp redness, swelling, site warm;
Patient fully vaccinated and hospitalized due to Covid. Patient started feeling sick on 9/4/21 with fatigue, shortness of breath, cough, congestion, body aches and loss of smell. Patient was in the hospital for 4 days, she was not in ICU or on a ventilator.
Information has been received from a physician concerning an 80 year old retired white female with no known allergies who on 08/20/2002 was vaccinated intramuscularly with a 0.5mL dose of pneumococcal vaccine 23 polyvalent (Lot # 1050-invalid lot).  It was reported that the patient had been previously exposed to this or a related drug in 1998.  On 09/09/2002, it was reported that the patient developed a large red swollen left deltoid following vaccination.  It is unknown if medical attention was sought.  On 09/09/2002 the patient was reported as recovered.  Additional information has been requested.
On 04/22/2022, early evening, I start feeling very tired. I slept for the next 24 hours.  I was very lethargic. I didn't call a doctor, I just slept it off.
ActHIB vaccine was inadvertently administered to a 2 months old patient from a shipment package that experienced a delayed transit time the placed on 28May2019, however package was not received until 31May2019/no AE; Initial information received on 04-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer (Office Staff).  This case is linked to case 2019SA157296 (same reporter).  This case involves a 2 months old female patient who was inadvertently vaccinated with a 0.5ml first dose of HIB (PRP/T) VACCINE [ACT-HIB] from a shipment package that experienced a delayed transit time (lot UJ128AAB, Expiration Date: 08-Nov-2020) via intramuscular route in the right thigh on 31-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE), DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and PCV13 (PNEUMOCOCCAL CONJUGATE VACCINE).  It was an actual medication error due to incorrect product storage. The product was placed on 28-May-2019, however package was not received until 31-May-2019.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  List of documents held by sender: none.
This case was reported by a pharmacist and described the occurrence of injection site soreness-muscle in a 65-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included seasonal influenza vaccine (non-gsk); Novartis; unknown; unknown given on 6 December 2012. On 7 December 2012 at 11:20 the subject received a dose of BOOSTRIX (.5 ml, unknown route, left arm). On 7 December 2012, less than one day after vaccination with BOOSTRIX, the subject experienced injection site soreness-muscle described as "sore muscle and tender muscle and surrounding area". On 8 December 2012, 1 day after vaccination with BOOSTRIX, the subject experienced shoulder pain in injection arm. "By the weekend, she experienced "pain left shoulder" also described as "left shoulder joint pain." At the time of reporting the events of shoulder pain in injection arm and injection site soreness-muscle were worse. The pharmacist stated that there was an "increase in the pain left shoulder and the site is getting progressive worse" but also reported that the "tenderness has subsided." The sore muscle was reported as unresolved. No further information was provided at the time of reporting. The pharmacist considered the events were possibly related to vaccination with BOOSTRIX.
Sudden onset full body myalgia and fever 102 less than 24 hours after injections.
I experienced sharp pain laterally through my deltoid muscle; ached/painful/ douloureux; Higher than normal blood sugar; This is a spontaneous report from a contactable consumer (patient herself). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not provided), via an unspecified route of administration in left arm on 27Jan2021 14:00 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. She had no allergies to medications, food, or other products. She was not pregnant. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications within 2 weeks of vaccination. The patient stated "I experienced sharp pain laterally through my deltoid muscle, ached/painful, and higher than normal blood sugar" on 27Jan2021 14:30. The events were reported as non-serious and no treatment was received. The outcome of the events was recovering. The patient had not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Getting the covid vaccine was worse than having covid itself for me. I experienced flu like symptoms. Body aches, chills, profuse sweating without a fever, soreness in arm at the injection site occurring 20 minutes after injection and is still sore, and a headache. All symptoms started, besides left arm soreness, early morning on oct 6 around 6 AM and continued until I went to bed around 9pm on oct 6.
Broke out in hives all over body. Rash on my arm, fever. Went to ER told me to take BENADRYL. No medication was administered by ER. (Latex bandage was applied to her arm which has the risk for allergic reaction).
COVID 19 Vaccine  Swollen arm at injection site.  Itchy but not painful
Pt developed nausea, diarrhea, lightheadedness, and elevated blood pressure.
A nurse reported that a child received a dose of Prevnar vaccine and immediately experienced burning at the the site and crying. The child recovered. MANUFACTURER'S NOTE: The reporter indicated that "all children" between the age of "2 months to 12 months" of age have experienced injection site but burning and crying however the reporter could not specify the exact number of patients. Additional reports will be generated when identifying information is provided. No further information was available at the date of the report.
Began with headache, persisted for about a week.  Then had numbness and tingling develop on left cheek, a new symptom.  Went to neurologist in his office on 09/28/2021.  Said he would refer for brain MRI which was scheduled for the following week.  Before that could be done, I woke up on 10/02/2021 at 6 am with extreme numbness and tingling on entire right face.  This persisted for hours, so went to the emergency room where they performed an MRI of the brain as well as several other tests.  I stayed overnight as they were concerned it might be a stroke.  Gradually got better and left the hospital the following afternoon, although the numbness on the right side of my face still persists today.  I feel a lot of nerves tingling and going up and down in my face and a mild headache persisting on and off all the time.
Woke up following day with pain in right jaw, ear, eye and head and gland. Dull constant pain on right side. Eye is watery and burning. One week of antibiotics did not change condition at all.
1 wk post vax began exp redness & warmth, pain in area persisted for 1 wk then began to subside; 1 mo later in area of injection necrotic area w/yellow drainage occurred a cm in size (on surface) on area that had remained hard; I&D done
13cm x 11cm red, hot sl indurated area @ site of tetramune immun rt thigh;
25APR91 pt recvd DTP/OPV/HIB & had fever, was unresponsive for several days; Fever started 25APR91 PM; Went to MD 26PR91; As of 30JUL91 pt is OK;
Tingling/numbness in left arm near injection site and in face and tongue. Began about 20 minutes after vaccine and continued until I took benadryl and the symptoms subsided.
I experienced severe diarrhea for at least 12-14 hours. I was in the bathroom at least once, sometimes more than once per hour.
Patient was scheduled for his first Moderna vaccine on Friday April 23rd at 3:00 pm. Intern administered the vaccine. After receiving the vaccination patient was instructed to wait in the designated waiting area for 15 minutes. After 5-10 minutes, patient walked over to the drop-off window and stated that he was having a hard time breathing and his hands were going numb. Pharmacist on duty, immediately left the pharmacy and walked over to the patient. The patient then fainted in his arms and pharmacist was able to gently bring him to the ground. Patient wanted pharmacist to call and notify his wife which at the time was waiting in her car. His wife arrived immediately. Technician, called 911 and ran EpiPen over to pharmacist and technician prepared a damp cloth and placed it behind patients neck. Pharmacist then administered one dose of adult Epi-pen. Minutes later patient still said he could not breathe and that his symptoms were getting worse. Pharmacist then administered second dose of Epi-pen. Within 3-5 minutes after receiving second Epi-pen dose, the ambulance came. EMT's gave the patient oxygen and placed him on a gurney. EMT's then took patient to ambulance and drove him to hospital. Going through patient's immunization consent form and in talking to patient, there was no indication that the patient has ever had any reactions to any vaccinations in the past.