chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. The patient was vaccinated intramuscularly with an expired dose of PNEUMOVAX 23 (H010515; 30-AUG-2012) on 31-AUG-2012. No other co-suspects or concomitant medications were reported. No adverse effect reported. Additional information has been requested.
got Mild side effects, had an allergic reaction consisting of hives on body including hands and legs, like 10 places; This is a spontaneous report from a contactable consumer, the patient. A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0150, Expiration date: did not have any as such), via an unspecified route of administration, administered in Arm Left on 09Apr2021, as dose 1, single (age at vaccination: 29 years), for covid-19 immunization. Medical history included appendicectomy on an unknown date in Mar2021 (had a surgery a month before first shot vaccination). The patient was not taking any concomitant medication. The patient stated that, within 3-4 hours after taking first shot, he got mild side effects, had an allergic reaction consisting of hives on his body including his hands and legs, stating there were about 10 hives (like 10 places) and they resolved in 2 days and he was fine. After that he was referred to CVC during that time during Apr2021 time, it was mention in CVC that he should not take any second shot even if he had some minimal allergic reaction (hives), so he did not get his second dose of the vaccine because of his allergic reaction. Reportedly, there was no prior vaccination and there was no family medical history related to adverse event. As a treatment for the event, he just went to Emergency and took Benadryl, for which he did not remember the dose. The outcome of the event was recovered on an unknown date in Apr2021.
Pt recv vax on 10/23/98;on 10/25/98 pt exp fever (104.4), red throat, sick x2 wk w/URI & otitis media; tx=Ceclor, Advil
COVID-19; COVID-19; This is a spontaneous report from a contactable pharmacist (reporting for herself).  A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), via an unspecified route of administration in the left arm on 22Dec2020 at a single dose for COVID-19 immunization.  There was no medical history and no concomitant medications.  The patient experienced COVID-19 on 28Dec2020, which was reported as being medically significant.  The patient underwent lab tests and procedures which included nasal swab test: positive on 29Dec2020.  Therapeutic measures were taken as a result of the event and included treatment with bamlanivimab on 30Dec2020.  The outcome of COVID-19 was recovered on 07Jan2021.  The causality was reported as no (unrelated); 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.
I had significant lymphadenopathy and lymphedema of the left axillary space starting about 24 hours after vaccination as well as significant arm pain at injection site and in my axillary space. The swelling lasted over a week, and there were prominent, palpable lymph nodes for at least a week or longer. The visible lymphadenopathy/lymphedema resolved after about a week and a half, but I developed mastitis of the left breast on 12/23-12/24. I am breastfeeding, and I have been since 2/1/2021. This is my third child to breastfeed, and I have never developed mastitis before. Since the affected breast was on the same side as the lymphadenopathy/lymphedema, I felt it possible that the vaccination and ADR may have contributed to my development of this breastfeeding complication.
did not feel well; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunisation. The patient past medical history and concomitant medication was not reported. The patient did not specify specific side effects, but she had side effects after the first dose of the Pfizer COVID19 vaccine and patient missed her second dose because she did not feel well, and she wants to make sure she feels completely well before getting it. The patient wants to know how long she can wait until she can get the second dose. The event outcome reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Extremely high pitched scream > than 1 1/2 hrs beginning 3 1/2 hrs /p vax given. Splotchy erythema on knees & chest beginning same time - duration of rash 2 hrs
hives; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (hives) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Singulair. Past adverse reactions to the above products included No adverse event with Singulair.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient takes singular and hadn't took any until. No concomitant medications reported. No treatment information was provided.
LOCATION OF INJECTION SWOLLEN TO SIZE OF "SMALL GRAPEFRUIT". SITE IS RED AND PAINFUL TO TOUCH.
Pt needed IPV and Varicella. He was given KINRIX (DTAP-IPV). This was his 6th DTAP. 45hrs after receiving it, he had 9 cm diameter area of redness & swelling surrounding the injection site.
Possible Vasovagal reaction. Patient was approximatly 7-10 minutes post dose. Upon video review of event patient was sitting and stood, waivered (appearing dizzy), lost consciousness and collapsed to ground. Remained unconscious for under 30 seconds. Observed various muscle flexing/tension  & uneven breathing. However patient never appeared to stop breathing. Patient did hit his head during fall & and was seen by EMS. During follow up patient was being seen in ED, but according to parents he appeared to be perfectly fine.
c/o palpitations, weakness, dizziness and fatigue. ST 120, COVID Pneumonia. started on abs, decadron. No hypoxia, remained on RA.
This spontaneous report was received from a nurse and refers to a 9 week old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 01-SEP-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) and ROTATEQ (dosing details not reported) (lot # M044397, expiry date: 20-JUN-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA007011:
Drugs (Lamictal & Bus-par) for Bi-Polar totally ineffective.   Drugs (Ropinerol) for Restless Leg Syndrome totally ineffective.  Symptoms subsided after 24 hours.
SICKNESS; SICK TO STOMACH; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sickness, and sick to stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sickness, and sick to stomach. This report was non-serious. This case, from the same reporter is linked to 20211240250.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Systemic: Cardiac Disorder (diagnosed by MD), Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Fainting-Severe, Systemic: hyporthyroidism vitmain d defiency; symptoms lasted 1 day
Took the first dose, after 9 days she got it, she got the Covid; This is a spontaneous report received from a contactable Registered Nurse (who is the patient, reported for self).   A female patient of an unspecified age received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number and Expiration date: Not Provided), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Reason for no lot number: of unspecified vaccine: Reporter was unwilling to complete the report. The patient medical history and concomitant medications were not reported. Other Products: Not Provided.   Reporter (the patient) was reporting on an adverse event of family member then reports adverse event on herself. Reporter stated that She herself took the first dose after 9 days she got it she got the Covid and its really not bad at all. Investigation Assessment was not Provided. Reporter declined to complete report for herself. The outcome of event was unknown.  Information on lot/batch number has been request
I had severe sciatica in my back and legs for all of February and most of March. I had tests run and everything came out fine, my doctor thinks it was related to the shot. I am still experiencing problems.
Patient states he is still experiencing pain at the injection site 1 month after he received the shot. There is no physical signs of any external or internal damage. No swelling, redness, or bumps at the skin around and near the injection site.
diagnosed with COVID19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with COVID19) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced COVID-19 (diagnosed with COVID19). At the time of the report, COVID-19 (diagnosed with COVID19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Mother states that the child began to have sorness at the area of vaccination about an hour after she received the vaccines. The following morning the child stated her right arm was so sore that she could not lift it to brush her hair. The child developed a large area erythemia and swelling to the fatty tissue in the back of her right arm in the area the Varicella vaccination was administered. The child went for a CAT scan for a follow-up on 8/14/09 due to post-nasal surgery infection and afterwards, rested because of the soreness. The mother called to report the event to the downtown immunization location and further details were discussed with myself at the Goodwill location. The mother stated the area was warm to the touch, but the child was having no difficulty breathing and did not have fever. Because the child has been finding new sensitivities to various foods and medications, it was advised to have the doctor follow up with her primary care provider. The mother did not mention the child had multiple chronic illnesses since the child has never had any problems with vaccinations.
Narrative:  74 yo male patient died on 8/3/2022 at home in full hospice care. Pt with feeding tube dislodged, abdominal pain, & cramping also with complications with bradycardia and decreased respirations when hospice care was initiated. Pt had received a covid EUA vaccine (J&J) on 5/13/2021. Death does not appear to be related to this vaccine given pt's age, in hospice care & long length of time between date of death & date patient received the vaccine. Patient did not receive the vaccine at this facility. He got vaccine from community pharmacy.
Swelling and pain under the arm, took liquid Motrin.  Pain lasted until Sat. AM.  She states that it felt like swollen/tender lymph nodes.
pt recv vax & broke out & lips swelling;back @ clinic 1130AM;whelps over most of body;upper lip swollen about 2 times nl size;
Adult received a pediatric dose; Adult received a pediatric dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 36-year-old female patient who received HBV (Engerix B pediatric) (batch number DDK7K7, expiry date 31-MAR-2024) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B ADULT).   On 28-FEB-2023, the patient received the 2nd dose of Engerix B pediatric .5 ml. On 28-FEB-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: Adult received a pediatric dose) and adult use of a child product (Verbatim: Adult received a pediatric dose). The outcome of the accidental underdose and adult use of a child product were 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: 17-APR-2023 The nurse practitioner reported that the patient inadvertently received a child dose of Engerix B as the second dose. The reporter called to inquire what protocol to got to and how to proceed. The reporter did not consent to follow up. The adult patient received a dose of Engerix B pediatric, which led to accidental underdose and adult use of a child product.
Rash at site that started within 2-4 hrs after injection and progressed to chest and R U/E within 12 hours. Redness, rash with itching noted.
Patient received a expired vaccine 22-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 22-Apr-2022) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 22-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 22-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 22-Apr-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Patient was diagnosed with COVID-19 positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. On 22-Apr-2022, the patient received the first booster dose of the vaccine. Patient did not have allergies to medications, food and other products. No Other vaccines were given within one month prior to Moderna COVID-19 vaccine to Patient. Patient did not have any acute and Chronic illnesses at the time of vaccination. Treatment information was not provided.
Subcutaneous administration of 25 units TU left tricep on 8/1/01. Call information center and was advised that no adverse reaction will be expected. Call CDC to speak to a professional about consultation issues, contacted the duty officer. Was told that the administration of the purified protein derivative will not sensitize a person if not already sensitive. There are no harmful effects to the child by the administration of PPD. The recommendation is to if the child needs to be tested, wait the 4-6 weeks after the MMR to minimize the risk of a false-negative response to the PPD. There are two issues. The units of PPD might increase the risk of false positive and the MMR might increase the risk for false negative. The time interval for PPD is the 4-6 week after as is recommended for the MMR. The consultant also stated if the client comes back with a positive, there may be uncertainty. The consultant recommends action, if the client tests positive to take action as if it was a true positive. Call other sources as noted. Spoke with nurse consultant reported no harmful effects to child by administration of PPD solution but to wait for PPD testing for 6-8 weeks as recommended for PPD testing after MMR vaccination.
Redness; Wheals; This spontaneous case was reported by a consumer and describes the occurrence of   in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I woke up around 2:00 am in pain all over my body. I was having chills so I took my temp and it was 100.6 My left arm @ injection site was swollen bigger than a silver dollar. This swelling worsened to the size of an Apple. I phoned my doctor and was advised to take Benedryl and Tylenol for the pain.
patient received second Moderna vaccine on Tuesday 8/31/21 around 1:00pm. developed fever on Wednesday morning which resolved, then he started having chest tightness and pain on inspiration on Thursday. Still bothering him today. I told him to see his doctor if it doesn't resolve by Sunday
Approximately 3 weeks after 1st Pfiser Covid Vaccination, started to experience severe pain in upper right side of back and chest in late evening of 3/24.  Pain continued to increase on 3/25. and was taken to emergency hospital.  Blood test and Cat Scan should Pulmonary Embolism, multiple blood clots in both lungs.  I was hospitalized and treated with Lovenox for two days.  Prescribed 10mg Eliquis twice a day. for 7 days and 5mg twice a day for 23 days
AFLURIA 2015-2016 - given 10/29/15. Pt. went to doctor 11/25/15. Has pain says shot hit the bursa in arm.
A few hours following vaccination patient reported being "knocked out" and explains that she slept for almost 12 hours which she normally does not do. Patient states when she woke up she was very confused, had trouble recalling simple facts such as place and time. Patient states she also had a hard time walking.
GBS- dx 6/4/99 by lumbar puncture & electromyogram p/3wk of increasing ataxia & gait instability, starting 1wk p/vax.
I received the shot at 12 p.m.   At 3:30 I began to experience rapid heart beat - dizziness when I stood up, feeling I needed to faint.  It has never happened before.
This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2022 as dose 3 (booster), single (Lot number: 33036BD), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Thalassemia Trait" (unspecified if ongoing), notes: Other medical history: Thalassemia Trait; "Mitral Valve Prolapse" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, lot number: EL3247, vaccine location: Left arm), administration date: 15Jan2021, for COVID-19 Immunization; BNT162b2 (Dose 2, single , Lot number: EM9810, vaccine location: Left arm), administration date: 07Feb2021, for COVID-19 Immunization, reaction(s): "palpitations", "severe chest pain". The following information was reported: PARAESTHESIA (disability) with onset 24Feb2022, outcome "not recovered", described as "Developed tingling"; LIMB DISCOMFORT (disability) with onset 24Feb2022, outcome "not recovered", described as "Feelings that there were shards of glass being thrown into my lower extremities"; FEELING HOT (disability) with onset 24Feb2022, outcome "not recovered", described as "Hot feeling"; PAIN IN EXTREMITY (disability) with onset 24Feb2022, outcome "not recovered", described as "most severe severe pain in my feet"; TEMPERATURE INTOLERANCE (disability) with onset 24Feb2022, outcome "not recovered", described as "sensations of heat". The events "developed tingling", "sensations of heat", "feelings that there were shards of glass being thrown into my lower extremities", "most severe severe pain in my feet" and "hot feeling" required emergency room visit. Therapeutic measures were taken as a result of paraesthesia, temperature intolerance, limb discomfort, pain in extremity, feeling hot. Clinical course: Developed tingling, hot feeling, and sensations of heat as well as feelings that there were shards of glass being thrown into my lower extremities within a few days of receiving the booster. Also had the most severe pain in my feet and legs and had difficulty walking (felt like patient was walking on my bones and there was no padding/flesh on the sole of my feet). Went to emergency room twice. Now being followed by podiatrist and neurologist. Patient treatment received as Toradol IV. Oxycodone PO. Gabapentin. Patient not had Covid-19 prior vaccination and not tested post vaccination. No known allergies. Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
pt recv vax & exp a sore throat over a period of time & nickel-sized rxn @ the inj site;no further details were provided;