chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received 1st dose from Moderna and 2nd  dose from Pfizer vaccine; Received 1st dose from Moderna and 2nd  dose from Pfizer vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received 1st dose from Moderna and 2nd  dose from Pfizer vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Received 1st dose from Moderna and 2nd  dose from Pfizer vaccine) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 07-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received 1st dose from Moderna and 2nd  dose from Pfizer vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Received 1st dose from Moderna and 2nd  dose from Pfizer vaccine). On 07-Jun-2021, PRODUCT ADMINISTRATION ERROR (Received 1st dose from Moderna and 2nd  dose from Pfizer vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Received 1st dose from Moderna and 2nd  dose from Pfizer vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received the second shot in the right arm on 07-Jun-2021 and its Pfizer vaccine. Patient reported no adverse events after taking both the doses of vaccine(1st dose Moderna and 2nd dose Pfizer) Patient provided the lot number for the second dose as EW0179 and the expiration date as 31-Aug-2021.  No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
some unusual symptoms after receiving a recent covid shot; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (some unusual symptoms after receiving a recent covid shot) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (some unusual symptoms after receiving a recent covid shot). At the time of the report, IMMUNISATION REACTION (some unusual symptoms after receiving a recent covid shot) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
This spontaneous report as received from a health care worker refers to unspecified patients of unknown age and gender. The reporter reported since 07-NOV-2014, an unspecified number of patients received doses of (Oka/Merck) VARIVAX (0.5 ml, subcutaneously) that had been improperly stored. No adverse events were reported. The outcomes of the events were unknown. This is one of the reports from the same reporter. Additional information has been requested.
outbreak of herpes; This case was reported by a nurse via sales rep and described the occurrence of herpes virus infection in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Acyclovir (PRN as needed for outbreaks, refer case US2022AMR161275).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced herpes virus infection. The patient was treated with acyclovir. On an unknown date, the outcome of the herpes virus infection was not recovered/not resolved.   It was unknown if the reporter considered the herpes virus infection to be related to Shingrix.   Linked case(s) involving the same patient:US2022AMR161275   Additional Information: GSK Receipt Date: 03-NOV-2022 Reporter's Comment: The patient was over 50 years of age, contracted herpes virus.  The patient received Shingrix shot and had an outbreak of herpes and now was taking daily acyclovir for continuous outbreak.  The patient reported to doctor that if she stopped taking daily Acyclovir that the outbreak re-started since, she received the vaccine.  The doctor advised her not to take the second shot of Shingrix. The reporter did not agree to follow up from GlaxoSmithKline.; Sender's Comments:  US-GSK-US2022AMR161275:same reporter, same patient
Received MMR and Td on 2/20/07. Developed rash on face 3/4/07 and chest area 3/5/07. Denies shortness of breath or pruritus. Patient given Diphenhydramine HCl 25 mg stg 1 PO every eight hours PRN and referred to facility reported.
After I administered the shot, patient fainted immediately.  He did start waking up after 30 seconds. I placed an ice pack on his chest and then he started refusing to be placed on the ground. Patient did recover after 30 minutes and was driver home by partner.
Pt left office, came back about 10 mins later with red swollen rash on face and spots on back and injection site. Pt was given BENADRYL in office.
moderate pain; tenderness; erythema; swelling measuring 10.0 cm; unable to go to work secondary to pain in her arm; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in the left upper arm on 30Jan2020 at a single dose for immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced moderate pain, tenderness, erythema, swelling measuring 10.0 cm and was unable to go to work secondary to pain in her arm on 30Jan2020. She denied any fever or systemic signs.  Therapeutic measures were taken as a result of the events and included: Ibuprofen and ice pack as needed.  The outcome of the events was recovered on 04Feb2020.    No follow-up attempts are possible; information about batch/lot number cannot be obtained.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 53-year-old female patient received BNT162b2 (BNT162B2), on 07Aug2022 as dose 1, single (Lot number: FP7138) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (ongoing), notes: Diabetic From: 14 years ago. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 07Aug2022, outcome "not recovered"; PYREXIA (non-serious) with onset 07Aug2022, outcome "not recovered", described as "Mild fever of 100.3 degrees Fahrenheit"; SUSPECTED COVID-19 (non-serious) with onset 07Aug2022, outcome "not recovered", described as "caller's kids think caller has Covid and caller is asking if caller had Covid"; LACRIMATION INCREASED (non-serious) with onset 07Aug2022, outcome "not recovered", described as "eyes feel weird/kind of watery"; PAIN IN EXTREMITY (non-serious) with onset 07Aug2022, outcome "not recovered", described as "her legs were hurting a lot"; BACK PAIN (non-serious) with onset 07Aug2022, outcome "not recovered", described as "low back hurting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information: Yesterday afternoon caller got the Pfizer shot, clarified caller got the Pfizer COVID-19 vaccine yesterday. Has a few questions because after getting the vaccine yesterday afternoon caller got a mild fever of 100.3 degrees Fahrenheit which caller took Tylenol for and still has the fever. Caller's legs hurt a lot, legs are still hurting a lot and low back is hurting. Caller has all these symptoms, caller's kids think caller has Covid and caller is asking if caller had Covid, could caller give Covid to kids. Caller is asking if when caller got the vaccine, could caller have gotten Covid? Caller eyes feel weird, kind of watery, like sunk, which started 07Aug2022. Has a headache, started 07Aug2022.
pt started screaming 15mins p/vax; screaming cont x 7hrs-unconsolable-lt leg swelled to double its size, red in color & shiny;no fever, pt given DPH w/some relief & also went to ER for MD exam
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Apr2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing); "Known allergies: bee stings" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient took Paxlovid Treatment from 15May2023 to 19May2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as unk (unknown dose number), single, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto" (unspecified if ongoing); "Thyroidectomy" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (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: Negative.
Initial report was received 03 December 2008 from a health care professional. A 56-year-old male patient with no known allergies and no past medical history, had received a subcutaneous left arm injection of VF VAX, lot number UF432AA, and a subcutaneous left arm injection of IPOL, lot number A0836-2, and an intramuscular left deltoid injection of HAVRIX, lot number AHAVB251CA (manufactured by GlaxoSmithKline) on 28 October 2008, and one week later, he developed a cough, nasal congestion, a headache and swelling at the elbow without pain (left or right not specified). The patient was evaluated by their physician, however their recovery status was not reported. The patient had no concurrent illnesses at the time of vaccination and had not been taking any concomitant medications. No additional information was provided. Follow-up information was received 29 December 2008 from a health care professional. The patient had swelling of the left elbow with a five cm diameter lump noted. The patient had been checked by their private medical doctor (PMD) however no relevant laboratory and diagnostic tests were performed and no treatments were prescribed. The patient recovered on 03 December 2008. No further information was provided. Follow-up information received on 24 March 2009 from a health care professional. The patient was reported to have been fine. However, he still had a small mass at his left elbow, which had decreased in size and was not causing him any discomfort. The patient did go on his trip without any problems from the lump. According to the reporter, the patient's physician did not know what caused the lump and couldn't state if it was from the vaccines that he had received. Documents held by sender: None.
Pt became febrile, 3 large hives noted on chest, face, flush, right neck tight.
Arm is swollen and hot to touch, red circle around area where shot was given and feels hard to the touch.
This spontaneous report as received from a registered nurse refers unspecified number of patients of unknown gender and age. On an unspecified date in February 2014 until 13-MAY-2014, the patients were vaccinated with doses of LIQUID PEDVAXHIB (doses, route and lot # not reported) that were improperly stored. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Approx 12hr after vaccine woke up from sleep with palpitations, heart skipping/ irregular heartbeat sensation. Home BP monitor indicated possible arrhythmia. Blood pressures elevated over next 10 days as high as 160s/90s. Over next month majority of BP readings elevated 140s-150s / 80s-90s, no previous dx of hypertension, had episode approx 6wk after where home monitor indicated arrhythmia, c/o ongoing symptoms at clinic visit 6/29/22
"Tingly" feeling in hand, numbness...entire arm was ice cold, pain at injection site, excessive bleeding.
Full body rash- lichen planus like; Head pressure; memory loss; This is a spontaneous report from a contactable consumer. A 43-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: ep7534), dose 1 via an unspecified route of administration, administered in Arm Left on 14Mar2021 14:00 as dose 1, single for COVID-19 immunisation (at the age of 43 years). Medical history included asthma and lichen from an unknown date and unknown if ongoing. Concomitant medications included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), zinc (ZINC), clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for an unspecified indication, start and stop date were not reported. The patient previously took wheat germ. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Mar2021 patient experienced full body rash- lichen planus like. Took several weeks to subside. Head pressure. Two weeks after severe memory loss, and I could not work. The patient received treatment with antihistamines. The patient underwent lab tests and procedures which included antibody test: positive on 01May2021. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was recovered. No follow up attempt are needed: No further information is expected.
Got vaccine 4/10/2021 4 days later started having left lower extremity swelling, on 4/22/2021 was diagnosed with DVT
Some patients were given Moderna after the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some patients were given Moderna after the expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some patients were given Moderna after the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some patients were given Moderna after the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  No treatment medications were provided.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URINARY TRACT INFECTION (non-serious) with onset 20Apr2021, outcome "unknown", described as "UTI". Therapeutic measures were taken as a result of urinary tract infection.  Additional information: Consumer had her first dose on the 07Apr2021 and scheduled tomorrow the 28th of April for the second dose. Patient had taken antibiotics for her UTI infection dated the 20Apr2021 and asking if it's safe to take the second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the Johnson and Johnson vaccine. After vaccination, she presented to clinic with a platelet count of 48,000. She was diagnosed with ITP by bone marrow biopsy on 1/28/22.
About 3 hours after the shot my upper arm was swollen and very sore.  The next morning I woke up with bad headache, dizziness, nausea and vomiting.  This lasted all day, the vomiting stopped by 11am.  It was so bad that I was unable to go to work.  The following morning better, but still a little headache and lightheaded.
Pt recvd MMR/HIB vax on 13JUL90; 7 days following vax pt devel t103 & higher; exp agitation; On 30JUL90 devel papular rash;
my skin bubbled up; I pointed the bubble out, I also bled quite a bit; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 13Apr2021 (at the age of 31-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 13Apr2021, Immediately after injection the patient experienced skin bubbled up and bled quite a bit The patient wanted to know if that would be an indication of not being administered correctly. The patient had given her dog subcutaneous fluids before and it had bubbled up like this. The person that administered the vaccine said everyone reacts differently. The outcome of skin bubbled up and bled quite a bit were unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Upon administration of my TDAP shot, my arm was extremely sore (perhaps consistent with a normal response). In the days immediately following the vaccination, my arm remained incredibly sore, making it difficult for me to perform normal activities (such as dressing). It is now 3 weeks after the vaccine was administered and my arm still has a constant dull ache that grows progressively worse if I am at my desk working. I have been taking OTC anti-inflammatory medication which helps only minimally. I returned to the clinic yesterday to report the ongoing discomfort and was told there is nothing that can be done at this point.
Fever of 104.7 on 11-15-06 rash on chest.
Gave a 16 year-old Kinrix instead of boostrix; Gave a 16 year-old Kinrix instead of boostrix; This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 16-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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 details were reported as follows: HCP reported via email inquiry that employees in his/her clinic gave a dose of Kinrix instead of boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter wanted to know how soon the patient could receive the ordered dose of Boostrix. No adverse events submitted. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR262207:Same reporter. Pt 2 - 17y/o US-GLAXOSMITHKLINE-US2021263815:FU1 - deleted
Began bleeding from rectum approximately eight hours after the injection, without related pain, but some discomfort. Bleeding occurs with or without a bowel movement. The first bleeding began without a BM. The bleeding lasted for approximately 10 days. The healthcare providers at the clinic have not provided any type of care at this point. They have decided without any kind of physical assessment (no temp check, pulse ck, BP ck, etc) that it is unrelated and probably hemorrhoid's even though I have never had hemorrhoids in my life. I reported history of polyps removed and of Colon cancer in father, grandfather and aunt. GF and aunt both died from colon cancer and dad from other cancer. Providers said to use hemorrhoid cream. and ordered tests. They concluded it's not related to shots without even touching me.
This spontaneous report as received from a doctor of pharmacy refers to a 69 years old female patient. The patient was vaccinated subcutaneously with ZOSTAVAX (lot number unknown) on 12-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. Six days later, on 18-JUL-2012 the patient noticed a lump beneath her skin. The reporter did not specify the size of the lump, but it had been getting smaller. The patient denied rash, itching or pain at the injection site. No treatment was given for adverse event. The patient consulted pharmacist for medical attention. The outcome of lump beneath her skin was reported as recovering. Additional information has been requested.
Rash appeared on trunk, legs, and tops of feet that itches and comes and goes in severity. (Likely hives).
Arm pain that radiated down arm and up shoulder and neck and fatigue started a few hours after shot. Later in the evening I felt very tired and body aches. Frequent urination. That night I got sweats and chills and more intense body aches. The following day symptoms got worse, even more chills, lots of sweating requiring changing clothes multiple times a day, frequent urination, dehydration, fever, severe body aches and weakness, severe nausea. It was difficult to get out of bed and walk. Low appetite. Cough and slight difficulty breathing. These symptoms continued at same rate for 48 hrs and started to get better then, fever went away but symptoms continued for at least 72 hours. Lingering cough continued past 2 weeks. When symptoms were most severe, I considered going to urgent care or ER but lacked ability to do so by myself.
Case number PHHY2011US60201 is an initial spontaneous report received from a physician on 05 Jul 2011. This report refers to an 11 year old boy. He was vaccinated with MENVEO (batch number: M10047) 0.5 ml, intramuscularly on unspecified date. But, the patient received 0.5 ml of only Men CYW-135 liquid conjugate without reconstituting it with Men A powder component. No adverse events were reported following this drug administration error.
Pt presented to the ED on 1/1/2022 with weakness, hypoxia, afebrile, sats in the mid 80s, productive cough - white sputum. CXR showed L lower lobe pneumonia, pericardial effusion. Tested negative for influenza and positive for Covid. Started on cefepime and dexamethasone, O2 at 2L and was admitted.