chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an employee of a distributor and a health care provider concerning a patient who on an unspecified date was vaccinated with Pneumovax 23. Subsequently the patients was hospitalized with swelling. No further details were provided. No further information is expected.
Ipsilateral axillaroadenopathy within 3 days post Tdap. Adenopathy resolved in 2 weeks. Then 3 weeks after Tdap sudden onset of profound weakness and dizziness lasting almost 3 month. No residual after episode resolved spontaneously.
Fever; Severe body aches; Felt weak the rest of the day; Having horrible diarrhea; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 28-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 16Jul2021 10:00 (vaccination at the age of 28 years) as dose 1, single for covid-19 immunisation at Doctor's office/urgent care. Medical history included irritable bowel syndrome, seasonal allergies and known allergy: crawfish from an unknown date and unknown if ongoing. Concomitant medication was reported as none as Other medications in two weeks were reported as no. It was reported that patient received no other vaccine in four weeks. The patient did not have Covid prior vaccination. On an unspecified date in Jul2021, the patient experienced fever, severe body aches, felt weak the rest of the day and was having horrible diarrhea. It was reported that, adverse event nearly 48 hours after injection he began having a fever and severe body aches. he got rid of the fever, felt weak the rest of the day, and his fever came back. He then began having horrible diarrhea that afternoon that had lasted over 24 hours, where he have had to go every hour since then. His fever has come back multiple times as well. The patient was not tested for Covid post vaccination. It was reported that no treatment was received for AE. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 12 hours after taking the injection, I woke up about 3 am feeling dizzy and nauseous. About 7 am I asked my wife to help me to the bathroom as I was unsteady on my feet and was feeling nauseous. I stayed in bed until 9 am and was then able to get up and move slowly without too much dizziness and feelings of being nauseous. By 6 pm I was almost back to normal but still felt somewhat unusual. By the next morning I was feeling normal.
SWELLING OF LYMPH NODE ON RIGHT SIDE OF NECK; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-MAR-2021, the patient experienced swelling of lymph node on right side of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling of lymph node on right side of neck. This report was non-serious.
binex: Positive/Covid test result=Positive; breakthrough infection/Covid test result=Positive; breakthrough infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 8 years as dose 2 (tris), single and (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 31Jan2022 08:00, outcome "not recovered", described as "binex: Positive/Covid test result=Positive"; COVID-19 (medically significant) with onset 31Jan2022 08:00, outcome "not recovered", described as "breakthrough infection/Covid test result=Positive"; INFECTION (medically significant) with onset 31Jan2022 08:00, outcome "not recovered", described as "breakthrough infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Jan2022) positive, notes: covid test type post vaccination=Nasal Swab,.  Clinical course: other vaccine same date product was not known. Patient not received any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Two days of nasal congestion, sore throat, and fatigue, followed by 7 days of nasal and bronchial congestion.  Three following days featured sinus congestion with notable pressure and fatigue.  Three following days of dry cough.
Fatigue; headache; rash on both legs with blisters, itching, pain, burning sensation appeared to be shingles (I have had shingles previously but no shingles vaccine) Lasted a total of 2 weeks until all symptoms were gone.
erythema, edema, pruritis and aching of right hand on top and palm especially at thumb
Felt warm and pain in upper back, 5 minutes after receiving vaccine. No numbness or tingling. BP - 140/90, pulse 62, O2 sat 100%. Patient rested and felt better. Resolved, went home.
Injection site reaction: erythema, edema, warmth, soreness xalmost 24 hours and ongoing.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 57-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because their facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. It was also reported that no adverse reactions were reported by patient.  No treatment information was provided.   This case was linked to MOD-2022-501575 (Patient Link).
Mild tongue swelling (tongue sticking out of mouth), low-grade fever (100), elevated heart rate (150-160), sleepiness, grunting, and strange raising of shoulders to the ears.
GOT PUT INTO NURSING HOME; This spontaneous report received from a consumer concerned a 9 decade old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: immune issues, and other pre-existing medical conditions included: It was reported that patient did not get COVID so far. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on unspecified date in APR-2021 for COVID-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received second dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on unspecified date in NOV-2021 for COVID-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced got put into nursing home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got put into nursing home was not reported. This report was non-serious.
Significant muscle pain starting in the upper right chest and then migrating to the left side about day 4.  Sharp, stabbing pain occurred when moving affected muscles, especially after being in lying position.
The patient reported to us today (1/10/22) that since her 3rd COVID vaccine, she has difficulty raising her right arm higher than (parallel to the floor).  I explained to the patient that this could be do to where the shot was administered.   I stated that she should follow up with her primary care physician since it's been so long since her vaccination and that she may require physical therapy to help with regaining total arm function.
On 08/22/2008 Child was taken to ER Via ambulance from her Day care where she had spiked a fever of  103, and experienced seziure like activity.  ER Physician gave Discharge Diagnosis of Febrile Seziure, Acute Pharyngitis.  Was treated with Rocephin 500mg IM, and was sent home with Amoxil 125 mg TID, Tylenol and Motrin Prn.   Went for follow up visit with regular Physician, who suggested the child may have had a reaction to the MMR given on 8/14/2008. Her notes indicate she spoke with Dr.with the Department of Health.
Fever of 101.5, chills, lethargy, and body aches on 5/6-5/7.  Widespread petechiae on arms and legs beginning the morning of 5/10 and spread through the evening of 5/11.   Slight tachycardia at rest. 110 bpm.   No other symptoms.   No treatment given.
Developed body aches and fatigue and headaches.  Developed a cough w/ congestion and took a COVID test and tested positive.  Called my doctor the next day and received Paxlovid.  After a day and a half I began feeling better.  I didn't finish the medication.
Vaccines were kept frozen until they are ready for administration; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. Vaccines were kept frozen until they were ready for administration which meant they would be in the fridge about 1 to 3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and was ready for the patients when needed. At worst case scenario they would have been in the fridge for about week if no one came in to be vaccinated. No treatment medication was provided by reporter.
Immediately after receiving the injection, my right arm ached. I thought it was normal. It has been 8 months and I can barely use my right arm without the muscle going into spasms. I have to rub arthritus cream on it 4 times a day. I can't sleep due to the aching. My doctor has given me two steroid shots into the deltoid tendon to try and decrease the inflammation. I do not see an end to it and will likely wind up at an orthopedic surgeon's office in the near future.
Information has been received from a medical assistant referring to a 8 weed old female patient. No relevant medical history or concurrent conditions were reported. On 11-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
sick for about 4 wks w/migraine like h/a on same side as vax; lymph nodes greatly enlarged in armpit & neck on 24OCT94 on vax side, never did go back down; have not had a well day since shot, plus got vistula detachment in both eyes;
Woke up with sore throat coughing nose dripping typical flu like symptoms on June 15th
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 27-DEC-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L031066, expiration date 18-AUG-2017; dosage, route and dose number were unknown). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested,
pt recv vax & devel redness, warmth, &/or soreness to the inj site;no tx was necessary;pt recovered;
Dizziness; tiredness; pain in her hips and knees; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FATIGUE (tiredness) and ARTHRALGIA (pain in her hips and knees) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination.     Concurrent medical conditions included Shaking of hands.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), FATIGUE (tiredness) and ARTHRALGIA (pain in her hips and knees). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), FATIGUE (tiredness) and ARTHRALGIA (pain in her hips and knees) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitantly patient was taking medication for shaking hand along with supplements.
Local injection site pain and swelling, 2 days, treated with ice, tylenol Body aches, severe, 2 days, treated with tylenol, rest Extreme fatigue, 2 days, treated with sleep for 24 hours
This spontaneous case reported by a patient, describes the occurrence of vaccination site pruritus (itchiness and swelling on injection site after a week) and vaccination site swelling (swelling on injection site after a week) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site pruritus (itchiness and swelling on injection site after a week) and vaccination site swelling (swelling on injection site after a week). At the time of the report, vaccination site pruritus (itchiness and swelling on injection site after a week) and vaccination site swelling (swelling on injection site after a week) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The patient developed itchiness and swelling on injection site after a week. Concomitant medications, laboratory data and treatment information not reported.
The patient stated that her joints had been hurting more since the shot this was mostly in the wrist (from thumb joint down). Then she woke on 4/20/21 with her shoulder hurting her and having brusising she described saying it looked darker and yellow in her wrist( from thumb joint down) and shoulder area.
Patient tested positive with Covid 19 after vaccination.; Patient tested positive with Covid 19 after vaccination.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient in his 30's received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient tested positive with Covid 19 after vaccination.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Patient tested positive with Covid 19 after vaccination. Clinical course: Patient was vaccinated with Comirnaty and subsequently contracted COVID 19. Patient is male, mid-30s, height and weight unknown. DOB unknown. Patient tested positive with COVID-19 after vaccination. Symptoms mild.  Follow-up attempts are completed. No further information is expected.
Presented with persistent cough, dx with covid 2 weeks PTA; admit to facility with Covid PNA; tx with maxipime, steroids, doxycycline, supplemental O2; back to baseline.  Disposition:She will be discharged today to home with home health.
I have MS and after day 4 of the 2nd dose I haven't been the same.; This 65- year-old male patient contactable consumer (reported for himself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EL9264), via an unspecified route of administration, on 13Feb2021 at 11:00 AM as a single dose for COVID-19 immunization, in left arm. The facility where COVID-19 vaccine was administered was at a Nursing Home/Senior Living Facility. Historical Vaccine included first dose of BNT162B2 on 23Jan2021 for COVID-19 immunization, lot number 11:00 AM, in left arm. She has had no other vaccines on the same day or in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included: Multiple Sclerosis, colitis, gastroparesis, asthma, and allergy to Penicillins. Concomitant medications were not reported. It was also warm to the touch. On 17Feb2021, the patient reported that I have MS and after day 4 of the 2nd dose I haven't been the same. Pain throughout my body and extreme fatigue. All my MS issues were brought to light and haven't left. The outcome of the events Pain throughout my body and extreme fatigue/ MS issues were brought to light and haven't left was not recovered. It was reported that since the vaccination, the patient had been tested for COVID-19 via nasal swab on 19Feb2021 with a negative result.
pt presented w/red quarter size welts all over leg;DTAP was given in lt leg;no welts were noted anywhere else on pt;
This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a adult patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number ZA72G, expiry date May 2019), (batch number 52B5N ?, expiry date May 2019) and (batch number 5FRCW ?, expiry date May 2019) for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated, an employee experienced a rather severe site reaction following administration of FLULAVAL. The healthcare professional did not have any additional information regarding the patients involved or the reaction. The reporter provided 3 lot numbers but unsure which ones might have been used 52B5N, 5FRCW, and ZA72G with expiration date of May 2019. The healthcare professional suggested she will gather additional information and requested to be contacted at a later time by Safety Department. The reported batch number 52B5N and 5FRCW for FLULAVAL QUADRIVALENT 2018-2019 season does not exist in sales database. This case has been linked with case US2018GSK193646, reported by the same reporter.
Patient received vaccine around 1255 pm on 3/31.  Upon standing after waiting the recommended 15 minute observation period, patient became dizzy, lightheaded. Patient's symptoms proceeded leading to brief loss of consciousness and pallor consistent with syncope. Patient was gently aided to the floor at 110pm. The patient's mother was present and accompanied the patient.  Patient was given general supportive care from pharmacy and team members consisting of feet elevation water, and head support.  At no point did the patient nor his mother request for emergency services to be contacted. A witness had EMS on the phone during supportive care. Before being able to inform EMS not to dispatch, they had arrived around 115pm. EMS took over care upon arrival. Blood pressure reading per EMS was 102/56.  Patient was transported to hospital at 1325.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml) (lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion for one time. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer) (R/F) were 216, 34 and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
After vaccination, the next day sore arm, by Friday I didn?t fee good and on Saturday I was hurting down my arm into my joints from top of neck all the way down arm. I had breast surgery 1 ½ ago and don?t know if its significant.  I was diagnosed with Shingles by my physician.