chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I did not feel well on April 17th. I had a terrible neck ache for 12-15 hours. It went away. Then I experienced a lot of coughing nonstop for 24 hours. On Sunday April 18th, my temperature got up to 104.  I continued to cough frequently. On April 19th, I went to the doctor's office. I took a Covid-19 test, which came back negative. I was diagnosed with acute sinusitis - even though I 100% believe that diagnosis was inaccurate. After going to the doctor's office, I started feeling better which was very odd. The coughing ceased and ended the next day.
Redness, swelling, and pain in upper right arm. Prednisone taper and ZYRTEC given at appointment 1/30/18. Has a follow up appointment on Friday 2/2/18. Symptoms started 1/29/18 after receiving vaccine at pharmacy.
She states "I sat down to get my shot and the next thing I knew everyone was standing over me".  EMS on scene reported that her syncopal spell lasted about 15 minutes after which she was found to be bradycardic and hypotensive.
Noticed redness, swelling and itching to injection site. Lasted 4 days. No treatment given.
Received 1st vaccination on 3/17/21 and developed sinus infection and cough the week of 4/22/21.  Tested negative for Covid-19 at CVS minute clinic and was prescribed doxycycline for 7 day for sinus infection.  Cough persisted but lessened.  Received 2nd dose of Pfizer on 4/7/21.  Cough began worsening on 4/13/21.  Went to emergency department on 4/16/21 for persistent cough.  Negative chest x-ray and negative Covid-19 test.  Prescribed 40 mg prednisone q day times 5 days and albuterol inhaler.  4/20/21 persistent dry cough remains.  Did not have cough before vaccination.  Not a smoker.  No history of COPD or asthma.
Site: Bruising at Injection Site-Mild, Additional Details: pt came to pharmacy on 09/12/2021 after receiving pfizer vaccine on 09/10/2021 -- very large bruise on arm starting upper arm extending to elbow. pt stated that bruise was spreading. very dark and edges defined with dark areas. advised to seek immediate treatment but was reluctant because no pain. stated on eliquis. said would contact her doctor monday. said normal  her pharmacy told her not to worry about it
Pt received first dose Pfizer COVID 19 vaccine 26JAN21 at approx 0830.  Pt reports yesterday 2330 went to pee and was feeling tired. Became nauseated and then started quickly oscillating between feeling hot and cold. Sat up in bed and when he did, felt ''everything move to my toes''. Remained conscious for about 2-3 seconds and then woke up on the floor in a pool of sweat about 5 minutes later (knows the timespan based on looking at his watch when he went to the bathroom and when he woke up). Tried to get up and felt unstable so decided to lay in the floor which he did for about another 10 minutes. During this timeframe, noticed jaw pain and soreness which he attributes to clenching his jaw. At this point, able to struggle into his bed and noted that the oscillation of hot/cold had abated and he was left with a mild headache and fatigue which has slowly improved since that time. At this time, pt reports he feels about 90% of USOH but somewhat ''uneasy'' still. Denies reaction to medication or vaccine in the past other than sulfa abx for which he had skin rashes as a child.
Body aches that progressed to splitting headache, nausea, body pain, 100 degree fever, joint pains.
COVID; COVID; Felt achy; Not feeling well; This is a solicited report (FACILITATED COLLECT) from a contactable consumer (patient), based on the information received by Pfizer from Regulatory Authority (Mfr. Control No. 21K-163-4084993-00).   A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on Mar2021 (Batch/Lot number was not reported) as dose 1, single, and second dose intramuscular on Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation; and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at citrate free for rheumatoid arthritis.  Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced COVID on Aug2021, not feeling well on 2021 and felt achy on 2021.It was reported that in 2021, the patient experienced might be not feeling well and felt achy after covid-19 vaccine. In Aug2021, the patient experienced covid. In 2021, the might be not feeling well and felt achy after covid-19 vaccine resolved.  The action taken in response to the events for adalimumab was unknown. The outcome of event COVID was recovering, the other events were resolved.    The reporter's assessment of the causal relationship of the reported events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  Causality for humira(adalimumab): the reporter's causality for the event(s) of might be not feeling well and felt achy after covid-19 vaccine was not provided. The reporter's causality for the event(s) of covid with humira(adalimumab) was a reasonable possibility.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective, COVID-19, pain and malaise  cannot be totally excluded. The case will be reassessed if additional information becomes available.
Lymphadenopathy, breast pain, swelling, tenderness.  started two days after second vaccine.  US and mammogram performed on 1/21.  had significant swollen lymph nodes on us warranting follow up in march for follow up. started taking motrin atc to decrease swelling.   lymph nodes were less swollen on follow up exam
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 17:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 48 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6199), in right arm, on 31Jul2021 as dose 2, single (Lot number: EW0150), in right arm and on 05Nov2021 as dose 3 (booster), single (Lot number: FH8028), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa allergy" (unspecified if ongoing); "Shell fish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Drug allergy: Amoxicillin"; Macrodantin, reaction(s): "Drug allergy: macrodantin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 26Oct2023 to 30Oct2023.  No follow-up attempts are possible. No further information is expected.
Has local reaction on left deltoid c/w warm, erythema, swelling, firmness. No evidence of secondary infection/cellulitis. No systemic reaction.
About 2 weeks after getting the vaccine, I smell smoke. Like fire smoke. It was almost constantly. The last few days I have noticed it has died down but for two weeks it was constant. No matter where I was I smelled it. It was everywhere I go I would smell this. I still smell it but just not constantly. In another two weeks I have an appointment to go see the doctor.
received from mother: states daughter received shot at approximately 10:00 a.m. on 7/9/21. Daughter tensed up right before getting the shot. Daughter now has pain running down right arm and has numbness in fingers of right hand. No complaint of swelling or redness.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 01-DEC-2017, the patient was administered an improperly stored dose of VAQTA, lot# N019924 with expiration date on 02-SEP-2018 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47.6 degrees Fahrenheit, which lasted for an unspecified time. There was no previous temperature excursion. A digital data logger was not involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA008157: US-009507513-1712USA008158: US-009507513-1712USA008160: US-009507513-1712USA008161: US-009507513-1712USA008162: US-009507513-1712USA002258:
Patient was 11 year and 9 months old, but by mistake gave adult Pfizer vaccine.
Initial information received on 11-Sep-2018 regarding an unsolicited pregnancy valid non-serious case received from a nurse. This case is linked to case 2018SA258056 (same reporter). This case involves a 30 years old female patient who received 0.5 ml booster dose of ADACEL (expiry date 22 June 2020 and lot details U5980DA) on 10 Sep 2018 while she was pregnant. The date of last menstrual period was reported as 23-Jan-2018. The estimated due date is 19-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient had no concomitant. It was a case actual medication error due to incorrect product storage as ADACEL too long in shipping (greater than 2 days) after dose given to pregnant female outside of stability recommendations. It was unknown if any adverse event occurred. 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 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. Documents held by sender: none.
ongoing sinus pressure and pain along with a 2-3 day history of recent onset of chills and myalgias, starting 11/23/21
2011 Influenza vaccine (FLUZONE) 0.5 ml IM given on 9/13 at 3:00 pm Lot # UH453AA exp 6/30/2012; Today (9/16/2011). She was working RN in PICU. She states she noticed on a.m. 9/14 swelling & "redness" over 3/4 of arm & forearm & over 9/14, 9/15, 9/16 swelling & erythematous area decreased starting in the center of area; presently area of erythema measures 110 mm wide x 160 mm long; BENADRYL 25 mg PO & ice pack.
Shortness of breath, diaphoresis, swelling of lips and tongue, redness of face, HR 140s, BP systolic 140s,
Numbness in face, throat, tingling.  It is 8:37 am next day, still continuing
dehydration; muscle spasms; dry heaving; muscle aches and pains; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 24 year-old female patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: DEHYDRATION (non-serious), outcome "unknown", described as "dehydration"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "muscle spasms"; RETCHING (non-serious), outcome "unknown", described as "dry heaving"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches and pains"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  Additional information: the patient was a physical therapy student who received second dose on Monday and had some muscle aches and pains which she expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swollen lymph node; This is a spontaneous report from a contactable consumer (patient).  A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Aug2021 (Batch/Lot number was not reported) age at vaccination of 30-years-old, as single dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) age at vaccination of 30-years-old, as single dose for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing (Penicillin allergy). The patient was not pregnant and was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen lymph node above left collar bone, lymph node became swollen two days after 1st vaccine on 14Aug2021. The event resulted in doctor or other healthcare professional office/clinic visit; the event was considered as non serious.  Saw doctor and ultrasound was done around 8 days after vaccine. Ultrasound performed on 20Aug2021 confirmed it was a swollen lymph node.  After 2nd vaccine, lymph node doubled in size (within 24hrs after vaccine). Doctor advised to wait two weeks after 2nd vaccine before making another appointment. It has been two weeks since the 2nd dose and lymph node is still swollen. No treatments were given for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Pfizer 6/28/21, 7/19/21, 1/22/22. Positive on 12/9/22
DVT blood clot; A spontaneous report was received from a 60-year-old male consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and developed deep vein thrombosis (DVT) blood clot.    The patient's medical history, as provided by the reporter, included factor V Leiden, enlarged prostate, DVT, pulmonary embolism and hypertension. Concomitant medications reported included valsartan, alfuzosin, and acetylsalicylic acid.   On 07 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 11 Jan 2021, the patient developed DVT blood clot and experienced leg pain so intense that he could not walk. A doppler exam showed the DVT was from the top of the calf to mid-thigh. Treatment for the event included a rivaroxaban starter pack with dose tapering.   Action taken with mRNA-1273 in response to the event deep vein thrombosis (DVT) blood clot was not reported.  The outcome of the event, DVT blood clot, was unknown.; Reporter's Comments: This case concerns a 60-year-old male patient with a relevant medical history of factor V Leiden, DVT, pulmonary embolism and hypertension who received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. Patient experienced the medically significant unlisted event of Deep vein thrombosis approximately four days after administration of vaccine. Treatment for the event included rivaroxaban. Based on the temporal association between the use of the product and the event occurring after receiving the vaccine, a causal relationship cannot be excluded and the event of Deep vein thrombosis is possibly related to the product. Of note, the patient's underlying Factor V Leiden which predispose to developing abnormal blood clots, and prior medical history of DVT with pulmonary embolism are considered risk factors to the occurrence of the event.
Recurrent Keratitis/ herpes zoster keratitis; This is a literature report for the following literature source(s).  A 32-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "herpes zoster keratitis" (unspecified if ongoing), notes: of his left eye 4 months earlier. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 09Mar2021, for COVID-19 immunisation. The following information was reported: OPHTHALMIC HERPES ZOSTER (medically significant) with onset 03Apr2021, outcome "recovering", described as "Recurrent Keratitis/ herpes zoster keratitis". The patient underwent the following laboratory tests and procedures: Slit-lamp examination: two new subepithelial infiltrates. Therapeutic measures were taken as a result of ophthalmic herpes zoster. Clinical course: A 32-year-old man with a history of herpes zoster keratitis of his left eye 4 months earlier, which was progressively improving, presented for a routine follow-up. He reported pain and pruritis in his left eye. Slit-lamp examination of his left cornea revealed two new subepithelial infiltrates. He had received his second dose of the Pfizer COVID-19 vaccination 3 days prior to the onset of symptoms. He was started on loteprednol twice a day and valacyclovir 1 g daily with progressive improvement of the symptoms at 1-month and 2-month follow-up visits.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported event Bacterial enteritis.Case will be reviewed on receipt of FU information. The impact of this report on the benefit/risk profile of the Pfizer product 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,Linked Report(s) : US-PFIZER INC-PV202300145291 Same article/ drug/event and different patient;
This spontaneous report as received from a physician refers to a 2 month old patient of an unknown gender. The patient's concurrent conditions and medical history were not reported. On 01-DEC-2015, the patient was vaccinated with first dose of ROTATEQ, orally (unknown strength and dose). On 01-DEC-2015 (today), a 2 month old patient was given first dose of oral, ROTATEQ and almost immediately the patient regurgitated the vaccine after it was given. The outcome of the events was unknown. Causality assessment was not provided. Additional information has been requested.
arm was a little sore; a little tired for a day or two; This is a spontaneous report received from a contactable reporter (Consumer).  A female patient of an unspecified age received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single; both via an unspecified route of administration on an unspecified date for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was a little sore"; FATIGUE (non-serious), outcome "unknown", described as "a little tired for a day or two". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: showed antibodies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021240087 same reporter/drug, different patient, similar events
Information has been received from a health professional concerning a patient who on unknown dates was vaccinated with PNEUMOVAX (lot # 660685/0619X). The patient experienced pain, swelling and unable to lift arm after getting the vaccine. Unspecified medical attention was sought. The outcomes of the evnts were not reported. This is one of several reports received from the same source. Additional information has been requested.
starting on 14Aug, have lost sense of smell and taste. Went for a covid test on 15Aug, which came back negative.; starting on 14Aug, have lost sense of smell and taste. Went for a covid test on 15Aug, which came back negative.; Second and third week after first dose, feeling unwell, constant cough, congestion.; Second and third week after first dose, feeling unwell, constant cough, congestion.; Second and third week after first dose, feeling unwell, constant cough, congestion.; Constant feeling of having a fever without having an elevated temperature; This is a spontaneous report received from a contactable consumer or other non hcp. A 51-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 27Jul2021 13:00 (age at vaccination 51years old) as single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks and Other medications in two weeks prior to the COVID vaccine. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Allergies: PCN. The patient's concomitant medications were not reported. Since the vaccination, the patient had been tested for COVID-19. The patient experienced constant feeling of having a fever without having an elevated temperature on 31Jul2021 16:00, and second and third week after first dose, feeling unwell, constant cough, congestion on Aug2021, starting on 14aug, have lost sense of smell and taste. went for a covid test on 15aug, which came back negative on 14Aug2021. The patient underwent lab tests and procedures which included sarscov-2 test: negative on 15Aug2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient came shopping in store on 12/26/18 stating she had an allergic reaction from SHINGRIX vaccination received on 12/15/18 - itchy red rash all over the body (not painful). Advised patient to call and see PCP immediately, but stated she has an appointment on 01/11/19.
Patient had complaintss of swollen right tear duct and swelling under eyes. No complaints of hives, itching, scrathy throat or difficulty breathing.
This is an administration error only. The patient did not report an adverse reaction today. She was immunized on 10/31/22 with a Pfizer-Bivalent 12+ injection but never received any primary vaccines.
UNDER MINIMUM CONDITIONS; This spontaneous report received from a patient concerned a male 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 not reported, batch number: Unk) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUL-2021, the subject experienced under minimum conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from under minimum conditions. This report was non-serious. This case, from the same reporter is linked to 20210743283.
Nurse administered .5ml booster instead of 0.25ml. No adverse reaction noted.