chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 12-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves patient (age and gender were not reported) who experienced "one adult patient received DAPTACEL instead of ADACEL/ no ae reported", while he/she received vaccine DAPTACEL instead of ADACEL (batch number, expiration date, dose, dose in series, route and site of administration were not reported for both the vaccines) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of an actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration. 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 holder's compliance with the requirements set out in Directive 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. Documents held by sender: none
2:50 pm EE increase heart rate per EE. Has HX of anxiety, felt better within 15 minutes.
CLIENT BECAME DIZZY AFTER RECEVING THE LAST OF 3 VACCINES. CLIENT REMAINED IN CHAIR, FEET ELEVATED. DIZZINESS ABATED AFTER 15 SECONDS. CLIENT REMAINED IN CLINIC FOR 30 MINUTES TO ENSURE FULL RECOVERY.
Injections site is swollen and hot to touch; Injections site hot to touch; Very hard large lump under the skin very red very painful; Very hard large lump under the skin very red very painful; Very hard large lump under the skin very red very painful; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 24May2021 at 09:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included blood clotting disorder and COVID-19. The patient was not allergic to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and acetylsalicylic acid (aspirin) (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26May2021 at 10:00, the patient experienced injections site swelling and hot to touch and had a very hard large lump under the skin which was very red and very painful. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events injections site swollen and hot to touch and had a very hard large lump under the skin which was very red and very painful were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Description: I received the spv last Thurs. Since last night I have been nauseated and have diarrhea. Also, notes cramping, diarrhea x5 denies bld. Stated everything goes through him including water. Is feeling dehydrated. Denies fever, and chest pn. Noted SOB, stated a co-worker had stomach flu last week. Symptom: Diarrhea Start: 12/10/2007; Symptom: Nausea w/o vomiting Start: 12/11/2007; Symptom: Abdominal Pain Start: 12/10/2007 Comment: described as cramping; Symptom: Dyspnea (shortness of breath) Start: 12/11/2007 Comment: told by ER it was due to dehydration
Warmth and erythema of left shoulder, itching 24 hours later. Keflex 250/5 T Tsp PO Bid, Benadryl 12.5/5 1 1/2 Tsp 26 PRN itching.
Raised rash emerged on hands and toes 6-7 days after 1st Moderna shot. This was on both the left and side of the body. The rash became large painful blisters that then turned into scabs after 15-25 on prednisone treatment. The steroid seemed to stop the progression of the rash as it was continuing to emerge on additional toes and fingers.
rt arm pain & numbness beginning 3 days p/vax; dx by neurologist brachial plexus neuropathy;
This spontaneous report was received via company representative from a pharmacist of unknown age regarding herself. Concurrent conditions and medical history were unknown. On 29-SEP-2015, three weeks earlier the patient was vaccinated with a dose of ZOSTAVAX (lot# unknown). Concomitant medications were not reported. On an unknown date approximately in 2015, the patient experienced rash at the injection site which was red, swollen and itchy and compared the rash to chicken pox. Varicella zoster virus identification program (VZVIP) packet was not sent. Treatment for the events included ice and hydrocortisone (unknown manufacturer). No medical attention was sought. It was unspecified if any laboratory diagnostics were performed. On an unknown date in October 2015, 10 days later the events resolved. Causality was not reported. Additional information has been requested.
had same thing (Literally thought I was going to die); three day coma; This case was reported by a consumer via interactive digital media and described the occurrence of coma 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 coma (serious criteria GSK medically significant) and impending doom. On an unknown date, the outcome of the coma was recovered/resolved and the outcome of the impending doom was unknown.   It was unknown if the reporter considered the coma and impending doom to be related to Shingles vaccine.     Additional Information: GSK receipt date: 10-Jul-2022 Reporter's comment: The case was reported by the patient's neighbor via interactive digital media. The reporter reported that the patient had same thing (horrific reaction to the shingles shot and thought was going to die) and a three day coma. Additional supportive information: Follow-up could be not possible as no contact details were available. The case was linked with case US2022AMR105421 and US2022AMR105409, reported by same reporter for different patient. As per reported narrative the patient had same thing as reporter therefore conservatively same events were coded this patient also.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105409:same report, other patient US-GLAXOSMITHKLINE-US2022AMR105421:tag at post
administrating the product after experienced a temperature excursion with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who experienced administrating the product Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent] after experienced a temperature excursion with no reported adverse event.  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 0.7 ml (frequency: once) suspect Influenza Quadrival A-B High Dose HV Vaccine lot UT8131DA, Expiry date: 30-Jun-2024) with unknown strength & formulation via intramuscular route in unknown administration site for Immunization after experienced a temperature excursion with no reported adverse event (poor quality product administered) (latency: same day) .  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Information has been received from a doctor of pharmacy concerning a 12 month old female who on approximately 25-OCT-2010 ("about two weeks ago") was vaccinated with a dose of VARIVAX (Merck) (lot# , dose and route not reported) without the knowledge of presence of unspecified neoplasm. It was reported that sometime after vaccination, patient was diagnosed with neoplasm and pharmacist inquired when to start chemo therapy when VARIVAX was administered "about two weeks ago". It was unknown if the patient sought medical attention. At the time of report, the outcome of neoplasm was unknown. Upon internal review, neoplasm was determined to be an other important medical event. Additional information has been requested.
Symptoms began with a headache on 12/10/09 and patient was diagnosed on 12/31/09 with Bell's Palsy at the E.R.
The day before my 2 weeks after my 2nd Dose of Pfizer, I woke up at 2:30 AM like I smelled something burning, almost like the smell of the smoke of 2 wires touching and it switched to more of a metallic smell. I had several other unpleasant smells. The smells kept changing and that lasted like 48 hours until I lost complete sense of smell and taste. 04/05/2021 I went to the ER, I was getting alarmed, because I did not know what was happening. I thought I was having a stroke. I went to the ER it was within the 48 hrs. span where I was having the phantom smells, right before I lost my taste and smell. They did blood work a CAT scan of my brain. They said I was not having a stroke. The ER doctor that treated me, was puzzled, with the lost of taste and smell. She referred me to a neurologist and and ENT. On Monday I got an appointment with the neurologist, and ENT doctor. By the time I saw my neurologist, I had completely lost my sense of smell and taste. The did a MRI scan of my brain, normal. And the ENT doctor CAT scan of my sinuses-some polyps. The neurologist had me get a COVID test before I went to the office and the result was negative. They put me on steroid and antibiotics in case there was an infection. The ENT, suggested Mind Breaker 100 % essential oils, I have been doing it for 8 weeks, but no results. I also felt brain fuzees and tiredness.
(L) arm injection site erythematous. 2 cms. oval erythema/induration. Patient placed on antibiotics and warm compresses to take care of local site cellulitis.
In evening of day of shots - She developed chills vertigo, nausea (still able to drink.) confined to bed - missed school next day. Mom states " this sensitive to shots"
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 72-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 10:45 as dose 5 (booster), single (Lot number: GJ6665) at the age of 71 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 20Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FP4554), in right 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: "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Sep2023, outcome "recovered" (14Sep2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Sep2023) Negative, notes: Began to test negative via home test on 14Sep2023. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 07Sep2023 to 12Sep2023. Clinical course: Patient did not have known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300333390 same patient, different drug/AE;
This spontaneous case was reported by a patient family member or friend and describes the occurrence of ERYTHEMA (red big circle on arm of injection) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red big circle on arm of injection). At the time of the report, ERYTHEMA (red big circle on arm of injection) outcome was unknown. Not Provided. No concomitant medications were reported. No treatment was reported for this event. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular)  was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up received on 13-May-2021 updated patient's DOB.
VERY itchy red bumps mainly on chest and a few on arms.   There is a large red circle and some swelling around the vaccination site.
Pretty aggressive inflammation in my sinuses; I lost my taste/smell; I lost my taste/smell; swollen lymph nodes; chills; fever; body aches; headaches; smelling smoke(campfire, not cigarette); This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (smelling smoke(campfire, not cigarette)), SINUSITIS (Pretty aggressive inflammation in my sinuses), AGEUSIA (I lost my taste/smell), ANOSMIA (I lost my taste/smell) and LYMPHADENOPATHY (swollen lymph nodes) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 011M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine and Levaquin).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAROSMIA (smelling smoke(campfire, not cigarette)), CHILLS (chills), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headaches). On an unknown date, the patient experienced SINUSITIS (Pretty aggressive inflammation in my sinuses), AGEUSIA (I lost my taste/smell), ANOSMIA (I lost my taste/smell) and LYMPHADENOPATHY (swollen lymph nodes). On 14-Mar-2021, PAROSMIA (smelling smoke(campfire, not cigarette)), CHILLS (chills), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headaches) had resolved. At the time of the report, SINUSITIS (Pretty aggressive inflammation in my sinuses), AGEUSIA (I lost my taste/smell) and ANOSMIA (I lost my taste/smell) had not resolved and LYMPHADENOPATHY (swollen lymph nodes) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: (Positive) tested positive for COVID-19. In January 2021, SARS-CoV-2 test: (Positive) tested positive for COVID-19.         No treatment information was provided.   This case was linked to MOD-2021-046849 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: added patient medical history , updated product tab , added events
Case previously recorded as MA2009-5687. Received on 20 NOV 2009 via MedCom, from a healthcare professional the following information: A 3-year-old female patient was vaccinated i.m. with 0.5ml FLUVIRIN, batch no. 10127801, on 20 NOV 2009. No adverse events were reported. MedCom no: NA09-008676.
OCtober 16-21 severe diarrhea, nausea, hives, sl fever 100.0;consulted MD, advised to take immodium, DPH, APAP;advised not to take flu shots again;
This is a spontaneous report received from a contactable other HCP, from a Pfizer-sponsored program (159558). A 15-year-old patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Oct 1, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Expired product administered to patient (patient administered expired vaccine), onset Oct 1, 2021, with outcome of unknown. Additional information: HCP inquired about recommendations for 15-year-old patient administered an expired vaccine Oct 1, 2021. Follow-up attempts completed. No further information expected.
At 30 minutes post vac Pt c/o n/v and "feeling tingly, sweaty and feeling anxious"  Pt. given Benedryl 25 mg  po and put on stretcher. Initial vitals 200/89  99%  HR 86. Pt then c/o heart fluttering.  EMS called and pt taken to Hospital
Headache, severe chills, severe body ache, fatigue, fever, shortness of breath, pain in location of shot, muscle ache,
On 1/28/02 at 05:00, pt had a fever of 103.2F with a body rash (hands, face, back, trunk, thighs) and increased crying. Motrin was given. Saw "jerking" movements. PCP states possible seizures. Saw PCP on 1/28/02. Noticed child was had imbalance and nurse referred mom back to PCP for evaluation of "imbalance".
soreness/a lot of; swelling in arm; mild redness; This case was reported by a nurse via call center representative and described the occurrence of pain in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX770AA, expiry date 7th July 2020) for prophylaxis.   On 8th July 2019, the patient received Bexsero. On 8th July 2019, less than a day after receiving Bexsero, the patient experienced pain, swelling arm and erythema. On an unknown date, the outcome of the pain, swelling arm and erythema were not recovered/not resolved.   It was unknown if the reporter considered the pain, swelling arm and erythema to be related to Bexsero.  Additional details were provided as follows: The reporter was the patient's mother. The nurse reported that, after vaccination with Bexsero, the patient experienced soreness, a lot of pain, swelling going down arm, and mild redness. These events were ongoing at the time of this report.
Fever 102 degrees F began same evening of vaccination, body aches and chills began then as well. Next day developed arthritic joints pain (in all joints) and progessively got worse. Developed headache that lasted 10 days. After headache developed full body hives. 9/10 pain when bloodflow cuts off. Worsens at night.
Worker received first dose of Pfizer at 13:20. Patient was observed for 15 minutes. During the time of her exit, observation provider noticed patient having a change in status and asked patient if she was okay. She stated that her "throat felt a little itchy."At that time observation provider escorted her into booth 11 for additional observation.  She was assessed by NP who gave her Allegra at 1341. Lungs were clear. She began cough and Epipen was administered at around 1343 at the left thigh.  Code blue was called as she appeared to be in distress.  By the time code team came, patient was stable.  IV started on left forearm and transported to Hospital ER and d/c. VSS-VS-130/81, HR 93, O2 100%
Client was given a Janssen covid-19 vaccine before noting that the client had written down that she received a covid-19 vaccine in December of 2020. (No record of previous covid-19 vaccine in record) Upon calling the client, she had received a Pfizer covid-29 vaccine in early December 2020 and she never received a second dose. Informed client of likely increased side effects from the  Janssen vaccine today and she voiced understanding.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 30 years, 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: "Crohns Disease (immune suppressed)" (unspecified if ongoing), notes: Crohns Disease (immune suppressed). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID (COVID 19 Treatment)  from 08Feb2023 to 13Feb2023.
Patient reported a weird sensation in his throat and chest pain during inspiration towards end of his recovery period. Patient able to take deep breaths. No other symptoms reported or noted. Vitals were taken: BP 130/72, HR 86, SpO2 at 98%. Patient had just received his 2nd dose of Pfizer and reported no issues with first dose. Patient was given water and monitored for 30 minutes. Patient reported feeling better and was advised to follow up with a doctor if symptoms of chest pain continued.
This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL 9, lot number M018810 with expiration date 28-MAY-2018, and lot number M031557 with expiration date 01-APR-2019 (dose, route and anatomical location were not reported) for prophylaxis. On 03-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 9.5 hours in the first cycle; Also on these dates from 04-JAN-2017 to 06-JAN-2017; from 09-JAN-2017 to 11-JAN-2017, on 13-JAN-2017, from 16-JAN-2017 to 20-JAN-2017, from 23-JAN-2017 to 27-JAN-2017 and from 30-JAN-2017 to 31-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 10 hours each day; all of them in the first cycle. In addition on 12-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 10.5 hours in the first cycle. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Hives, diphenhydramine, famotidine. Resolved after 10 days.
Fever (~100°) lasting more than 24 hours, severe body aches starting 8-9 hours after shots and lasting about 16 hours.
The symptoms listed just started. Will require continued tracking for resolve. Low grade temp (99.0-100.4) Sore throat  Swollen eyelids
Client began to experience dizziness and nausea following vaccine administration.  Fire Rescue at scene to assess client.  All vitals within normal limits.  Clients dizziness and nausea began to resolve.  Client offered transport to ER as precaution and refused.  Client felt normal and drove out of park at 10:15am.