chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 48year old. The patients height, and weight were not reported. The patients concurrent conditions included diabetes, non smoker and non alcohol use and other pre-existing medical conditions included the patient have no known drug allergies and no illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25-MAY-2021) dose was not reported,1 total administered on 20-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021, the patient had taken blood test for IgG (Immunoglobulin G) /IgM (Immunoglobulin M) and the results were negative. On 05-MAY-2021, the patient had again taken blood test for IgG (Immunoglobulin G) /IgM (Immunoglobulin M) and the results were negative (confirmed immunological vaccine failure). It was reported that the reporter came to know that the patient was not developing antibodies to the COVID-19. The patient was diabetic and the reporter wanted to know that they can use another brand of covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed immunological vaccine failure. This report was serious (Other Medically Important Condition). This reported was associated with product Quality complaint: 90000178960. The suspected product quality complaint has been confirmed to be not voided (meet PQC criteria) based on the PQC evaluation/investigation performed. This case is a duplicate of 20210513497.  Following receipt of additional information, it was determined that nullification was required for Manufacturer Case Number [20210513497]. The information indicated that Manufacturer Case Number [20210533028].Therefore, this case Manufacturer Case Number [20210533028] was created to correct the country of primary source. All relevant information will be submitted under Manufacturer Case Number [20210533028].; Sender's Comments: V0: 20210533028-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Heart palpitations; Tachycardia; shortness of breath; numbness in arms and body more on left side; eyelids very tired and droopy; chest pain; nausea; vomiting; diarrhoea; abdominal pain; cold sweats; drastic body temperature change; bottom lip swelling; headaches; lightheaded; cold hands and cold feet; flushing warmth in face; tingling sensation in hands and feet; increased blood pressure; Blood pressure decreased; foggy brain; memory lapses; blurry vision; This is a spontaneous report from a contactable other healthcare professional. A 28-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 2 via an unspecified route of administration, administered in Arm Left on 29Jan2021 17:45 (at the age of 28-years-old) (Batch/Lot Number: EL9262) as dose 2, single for covid-19 immunisation. The patient medical history was reported as none. Concomitant medications included docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), multivitamin, vitamin d3 and vitamin c (ascorbic acid). Start and stop dates of all concomitant medications were not reported. There were no known allergies. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Jan2021 17:45 (Batch/Lot Number: EL1283) for covid-19 immunisation. The patient did not receive any other vaccine within 4 weeks of covid-19 vaccine. On 29Jan2021 19:30, the patient experienced heart palpitations, tachycardia, shortness of breath, numbness in arms and body more on left side, eyelids very tired and droopy, chest pain, nausea, vomiting, diarrhoea, abdominal pain, cold sweats, drastic body temperature change, bottom lip swelling, headaches, lightheaded, cold hands and cold feet, flushing warmth in face, tingling sensation in hands and feet, increased blood pressure, blood pressure decreased, foggy brain, memory lapses and blurry vision. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Laboratory tests on an unspecified date included: blood pressure was increased, blood pressure was decreased, body temperature showed drastic body temperature change and on 20Feb2021 sars-cov-1 test was negative (nasal swab). The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Vaccine had been punctured for 26 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
I had a sore arm. Then I got sick and my back hurt really bad.  I went to the ER.  They said I had a kidney infection.  I also got tested for Covid-19, which came back positive.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender with a history of chickenpox as child. On unspecified date around 2010, the patient was vaccinated subcutaneously on left deltoid with ZOSTAVAX (lot# and dose information were unknown). The patient developed herpes zoster on 13-AUG-2012. No rash occurred at the site of injection. Lesions were located at left anterior and posterior chest wall, and lesions were too numerous to count. It took 25 days for rash to resolve. The patient's max temperature was 98.0. Pain was quantified as 9. Other systemic symptom included fatigue. There was no recent exposure to chickenpox or herpes zoster. There was no direct fluorescent antibody done. There was no specimen collected for PCR. On an unknown date, the patient  recovered. This is one of several reports received from the same source (1209USA002361, 1210USA004890). Additional information is not expected.
Assessment/Plan: 1. Adverse effect of vaccine, initial encounter (Primary) 2. Sore throat   1.  Left axillary region swelling and discomfort after COVID-19 vaccine.  Symptoms improving and reassurance provided, discussed that this is a common side effect.  If swelling or tenderness is still present 4 to 6 weeks after the Covid19 vaccine, she should return for evaluation. 2. History consistent with viral etiology and symptoms are improving.  Recommend supportive care and we discussed rest, fluids and use of OTC medications such as  anti-pyretics for symptoms. Symptoms should resolve within two weeks of onset.  If symptoms persist or worsen recommend follow-up.
This case was reported by a consumer via call representative and described the occurrence of muscle pain in a 50-year-old female patient who received BOOSTRIX (batch number LF444, expiry date 10th September 2016). The patient's past medical history included seizure. Concurrent medical conditions included vaginal hysterectomy (partial hysterectomy) and penicillin allergy. Concomitant products included APRISO. On 23rd December 2014 10:00, the patient received BOOSTRIX (intramuscular). On 25th December 2014, 2 days after receiving BOOSTRIX, the patient experienced injection site warmth and injection site pain. On 27 December 2014, the patient experienced muscle pain and muscle spasm. On an unknown date, the patient experienced difficulty breathing. On an unknown date, the outcome of muscle pain and muscle spasm were recovering/resolving and the outcome of the injection site warmth, injection site pain and difficulty breathing were recovered/resolved. The reporter considered the muscle pain, injection site warmth, injection site pain, muscle spasm and difficulty breathing to be related to BOOSTRIX. Additional information received: Caller reports that she has been experiencing extreme muscle pain and spasms since receiving the BOOSTRIX vaccine. About two days after the vaccination she had some pain at the injection site and it was warm to the touch. About 4 days after the vaccination she developed severe muscle pain and spasms. The spasms started in her hands and feet and she couldn't unclench them. Since the spasms have travelled to different parts of her body. About 2 weeks after the vaccination she saw her HCP because the muscle spasms had travelled into her lungs and she had a hard time breathing. The spasms will stay in an area of her for several days and then move to another area. Currently she says the spasms are improving, but have not left. They have been in her neck and shoulders for a couple days. The muscles that are spasming are tight and painful the whole time, until it moves to another part of her body. Her HCP has told her that this is a reaction to the BOOSTRIX vaccine, and that she will just have to wait it out. She did receive a prescription for inflammation pills, but she has completed the course.
pt recvd vax & had pain and swelling at site; inflammation of joints; paresthesias; felt like needle stabbing from midshoulder to forearm; hard knot; n; v; back pain;
The joint pain is in her shoulders, wrist, fingers, elbows, knees, hips, ankles, and toes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 (Lot number: EW0162) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL. Vaccination history included: Bnt162b2 (First dose; left arm;, Lot no: ER8734), administration date: 08Apr2021, when the patient was 39 years old, for COVID-19 immunization, reaction(s): "Severe Joint pain", "pain in her neck". The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "The joint pain is in her shoulders, wrist, fingers, elbows, knees, hips, ankles, and toes". The event "the joint pain is in her shoulders, wrist, fingers, elbows, knees, hips, ankles, and toes" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia.  Additional information:Concomitant Products Tylenol patient Took right before the vaccine. The caller wants to report a potential side effect. The caller took the second vaccine at the end of April, since the first dose she has had severe joint pain throughout her body. The joint pain was in her shoulders, wrist, fingers, elbows, knees, hips, ankles, and toes. At first the caller's doctor said to wait 8 weeks after the second dose to see if it will go away but it was still persisting. The caller has has an appointment tomorrow with a rheumatologist. The caller knows that there has been reports of joint and muscle pain which actually goes away after about 8 weeks. Its has now been 4 months for the caller with no signs of the joint pain going away. This event began a week after the first vaccine. The caller's doctor ran an autoimmune scan and blood work. The caller has low titters for RA but the doctor ran it a week after the second dose so it could be that. The caller states that we can contact her PCP for this information. Time the Vaccination Was Given: 1:00 or 2:00.Prior Vaccinations (within 4 weeks): None.The caller's neck seems to have pain in her neck and her doctor thinks it was an infection. It happened around the time of the first vaccine so the caller doesn't know if it is related. They caller took 3 different antibiotics and that didn't do anything. The caller is unsure of the names of two of the vaccines, one started with a C and the last one she took was Amoxicillin. The caller does not know the lot, NDC, and expiration date for the 3 antibiotics.  No follow-up attempts are possible. No further information is expected.
Tired; This case was reported by a consumer and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2019, the patient received Shingrix. On 25th September 2019, 1 days after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient reported that the patient received a Shingrix vaccination yesterday and feeling tired at the time of reporting. The asked if this was normal.
I administered this vaccine, after which client said "Oh, this isn't the H1N1 flu vaccine? I already got the regular flu shot 2 weeks ago.
101° Fever, severe Headache, difficulty breathing, swelling of lips, anxiety, severe swelling at the injection site,  muscle aches
Sore, lump, red, and itching at the site. Symptoms started 24 hours after injection. Also "lumps" inner aspect of the upper arm. No treatment.  A follow up report received 10/18/2001 adds: Pt reports she has almost completely recovered from site reaction. Had no other vaccine at that date; has had no other vaccines in past month. Has had flu vaccines for the last 3 years and has never had an AE previously.
Vertigo lasted about 3 hours; Enlarged Nodes underneath Armpit where I received injection shot lasted for 35 days.; This is a spontaneous report from a contactable consumer, the patient.   A 69-year-old non pregnant female patient received BNT162B2 (Pfizer BioNTech Covid 19 Vaccine) (Lot/batch no: EL9264) via unspecified route of administration at right arm as a single dose for COVID-19 immunisation on 12Jan2021 at 10:00 am. No medical history and concomitant drugs were reported. The patient was allergic to medications, food, or other products. Reported 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 and since the vaccination, the patient was not been tested for COVID-19. The patient experienced vertigo lasted about 3 hours and enlarged nodes underneath armpit where she received injection shot lasted for 35 days on 12Jan2021 at 10:15 am. No therapeutic measures were taken as a result of these events. The patient did not receive any treatment for the events. The clinical outcome of the event vertigo and enlarged nodes underneath armpit was recovering. No follow-up attempts are needed. No further information is expected.
Pt developed infectio nat site of vaccine administration. I & D done at ER visit currently undergoing abx rx.
Patient became hot, red, and itchy systemically 15 minutes after receiving the shot.   Gave 50mg of benedryl and observed for 45 minutes.   Symptoms resolved.    Called patient later in the afternoon and symptoms had not come back.
This spontaneous case was reported by a physician and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (7-Year-Old received 5-Month to 6-Year-old formulation vaccine for first dose/Received 0.25 ml of 5-Month to 6-Year-old formulation  for first dose), ACCIDENTAL UNDERDOSE (Received 0.25 ml) and NO ADVERSE EVENT (No adverse event) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (7-Year-Old received 5-Month to 6-Year-old formulation vaccine for first dose/Received 0.25 ml of 5-Month to 6-Year-old formulation  for first dose) and ACCIDENTAL UNDERDOSE (Received 0.25 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (7-Year-Old received 5-Month to 6-Year-old formulation vaccine for first dose/Received 0.25 ml of 5-Month to 6-Year-old formulation  for first dose), ACCIDENTAL UNDERDOSE (Received 0.25 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (7-Year-Old received 5-Month to 6-Year-old formulation vaccine for first dose/Received 0.25 ml of 5-Month to 6-Year-old formulation  for first dose) and ACCIDENTAL UNDERDOSE (Received 0.25 ml). No Concomitant medication was reported. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Aug-2022: Follow-up received included non-significant information updated reporter's information.
pt recv vax 10JUN98 & 14JUN98 pt could not get a breath: felt like an asthma attack & exp achy feeling, nausea, lower abd cramping, low grade temp, diarrhea & no appetite;
Shortmess of breath, bluriness, no balance, fractured nose from fall, passed out.  Arm welt size of baseball hot above where shot was given, diarrhea, nausea, low blood pressure
Ankylosing spondylitis flares up after Covid vaccines; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4148818.  A 49-year-old female patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), on 08Apr2021 as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) as unk (40mg/0.4ml) subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "not recovered", described as "Ankylosing spondylitis flares up after Covid vaccines". The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of ankylosing spondylitis.  The reporter considered "ankylosing spondylitis flares up after covid vaccines" related to BNT162b2.  Causalities: The reporter's causality for the event(s) of Ankylosing spondylitis flares up after Covid vaccines with Adalimumab Solution for Injection was Reasonable Possibility The reporter's causality for the event(s) of Ankylosing spondylitis flares up after Covid vaccines with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility Company's opinion was that the causality for the event(s) of Ankylosing spondylitis flares up after Covid vaccines with Adalimumab Solution for Injection was Not Provided Company opinion was that the causality for the event(s) of Ankylosing spondylitis flares up after Covid vaccines with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.  Assessment Results: Humira 40mg/0.4ml:  Spondylitis ankylosing aggravated, Non-Health Care Professional, Global Introspection, Probable. Humira 40mg/0.4ml: Spondylitis ankylosing aggravated, Market Authorization Holder (MAH) Pfizer BioNTech COVID-19 vaccine: Spondylitis ankylosing aggravated, Market Authorization Holder (MAH) Pfizer BioNTech COVID-19 vaccine: Spondylitis ankylosing aggravated, Non-Health Care Professional, Global Introspection, Possible Clinical Course: It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Treatment Drugs: The patient was treated with Cymbalta  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the events  and the suspect drug  BNT162b2  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 had a mild perianal cellulitis. Positive staph culture treatedwith Cephalexin on 4/14/00. Took 4 doses then vomit and diarrhea on 4/15/00. No fever, malaise, decreased appetite, elevated perianal rash.
This is a non-serious spontaneous case from a healthcare professional in the USA reporting that a medical support member had ACCIDENTAL EXPOSURE to FluMist while vaccinating military personnel. The reporter determined the events to be unrelated to FluMist administration. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. An unidentified medical support member developed headache and scratchy throat after accidental exposure during FluMist administration. Investigation into these events resulted in no definitive reason why the FluMist was responsible for these symptoms. The reporter determined the events to be unrelated to FluMist vaccination. Further information has been requested. Follow up received states - This is anon-serious spontaneous case from a healthcare professional reporting that a medical support member had ACCIDENTAL EXPOSURE: (Unlabelled) to FLUMIST while vaccinating military personel. The reporter determined the events to be unrelated to FLUMIST adminstration. This case is submitted according to the VAERS Safety Surveillande accelerated reporting agreement for FLUMIST. A 26 year old male medical support member developed headache and scratchy throat after accidental exposure during FLUMIST adminsitration. Investigation into these events resulted in "no definitive reason" why the FLUMIST was responsible for "these symptoms." HEPA filters were put into the environment and since then, nobody has gotten sick. The patient has recovered. The reporter believes military personnel that were vaccinated with FLUMIST were already sick and hence may have caused the individuals administering FLUMIST to have headache and scratchy throat. The reporter determined the events to be unrelated to FLUMIST vaccination. Additional information received on 05Jan05 and 19Jan05 incorporated into above narrative. Additional information received on 04May05: patient name, gender and DOB; vaccine lot number