chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via representative refers to a female patient of unknown age. On 18-DEC-2014 the patient was vaccinated with ZOSTAVAX (lot # K000330, expiration date in March 2015) (dose and route unspecified) in the left arm. In December 2014 the patient experienced redness at the injection site on her left arm described as "it resembled a mosquito bite or a bug bite", she felt "hardness" and it was "welt" where the injection was given. The pharmacist stated the patient's back started to hurt after ZOSTAVAX vaccination. The patient had sought medical attention. No treatment was given. The events outcome was unknown. Additional information has been requested.
Allergic reaction to the first two vaccines; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) 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, reaction(s): "Allergic reaction to the first two vaccines". The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergic reaction to the first two vaccines".  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-PV202300067780 same patient/drug/AE, different dose;
Pt. turned white and became sick/feel nauseated after getting Hep A and Yellow fever , which came on several minutes after YF given then she fainted w/eyes wide open for about 3-4 seconds. Called and tapped her until she woke up. While fainted, she was sitting on a chair so she just slouched down and had her head to the side. After she woke up gave pt. some cold water and had pt. sit and rest about 20 min. then she said she's feeling fine for last shot (IPOL). Pt. rested about 15 min after last shot and said she's feeling fine; then she left. F/u - u/pt. on Saturday and she said she has no other problem/adverse events.
TDAP administered 9/20/10. Employee states 9/21/10 (L) arm painful w/ fever. 9-27-10 Employee reports symptoms to Employee Health. Temp 99.8. Employee states she did not have fever and felt bad.
has been exposed to his wife who has been tested positive for COVID after receiving the first dose of Pfizer's COVID vaccine; This is a spontaneous report from a contactable consumer or other non hcp.   A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient has been exposed to his wife who has been tested positive for covid after receiving the first dose of pfizers covid vaccine on an unspecified date. The outcome of the event was unknown.  The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Feb2021.  The action taken in response to the event(s) for bnt162b2 was not applicable.  Follow-up attempts are completed. No further information is expected.
Patient described cloudy, blurred vision about 5 minutes after injection in the pharmacy lobby. Patient was led to clinical room for observation with mother and sister. Administered three blood pressure readings, gave her water and donuts. Blood pressure was low but improved over 15 minutes. After 3rd reading blood pressure improved and we let her go.
Patient is a 35y/o G5P3013 with known Kell alloimmunization being followed in our fetal care center.  EDC was 1/14/22. She was receiving weekly IVIG since 11 weeks gestation secondary to prior affected pregnancies requiring multiple transfusions. She had no evidence of fetal anemia based on weekly fetal middle cerebral artery peak systolic velocity (MCA-PSV) Dopplers. On 8/25/2021 at 19 weeks 5 days during routine MCA-PSV screening she was noted to have a large subchorionic bleed by ultrasound and the patient also reported vaginal spotting. The patient was followed expectantly and had preterm premature rupture of membranes on 9/1/21 at 21 weeks 2 days. The patient was admitted on 9/17/21 at 23 weeks o days and received a course of betamethasone, magnesium sulfate and latency antibiotics. She went into spontaneous labor on 9/25/21 at 24 weeks 1 day and the neonate unfortunately died at 9 hours post delivery.
Hardness at site of vaccination within a few hours of administration and shoulder pain. Now with neck stiffness (onset 9/22) which is the cause for her report. No fever.
This spontaneous report was received from a nurse prescriber referring to a 14 year old male patient. The patient's medical history and drug reactions or allergies were not reported. In March 2014 the patient received the first dose of his human papilloma virus (HPV) vaccination series with GARDASIL for prophylaxis (strength, route, dose, units, frequency or lot number were not reported). In July 2017 the patient received the second dose of his HPV vaccination series with GARDASIL 9 for prophylaxis (strength, route, dose, units, frequency or lot number were not reported). No adverse effects were reported.
pt says as he was getting the vaccine, they put the needle in his arm and as they were pushing the syringe blew up so both the pt and the vaccine administrator both got sprayed with the vaccine solution.  The patient says his arm was bleeding and he has no idea how much of the actual vaccine he received.
Left neck adenopathy/mass with pain, limited ability to open the mouth.  Solumedrol IM and oral benedryl provided, patient sent to ED for observation, management
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient was vaccinated with VARIVAX (Merck). Other suspect therapies included PROQUAD (Merck). No concomitant medications were reported. Nurse reported that a patient received a dose of VARIVAX (Merck). and a dose of PROQUAD (Merck) during the same visit at an unknown date. No symptoms reported. No other details. No treatment information was reported. Additional information has been requested.
Fatigue, weakness in legs and arms, fever of 102.2 , tiredness, stuffy nose, headache, chills, and hot flashes with burning sensation of lips.
Developed Covid arm second day post vaccination then a few days later when that resolved facial rash appeared.    Dermatologist dx. as rosacea.
pt recv 2 doses of vax by mistake & felt faint for a short time p/ vax;
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021 at 4:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2021 at 4:14 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 27.26.  Concomitant products were not provided.  On 27-Feb-2021, Excursion time was 09 AM, 11 AM, 12 PM, 1 PM, 2 PM, 3 PM, 4 PM and 5 PM, the temperature was 33,35,35,35,35,34,34 and 35 respectively. total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  Vial was stored on cooler 1, on 27-Feb-2021, Excursion duration at 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 AM: 35, 1PM: 35, 2 PM : 35, 3 PM: 34, 4 PM: 34 and 5 PM: 35.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Nausea/vomiting/diarrhea, abdominal cramping and pain, headache, body aches (specifically pelvis and shoulders), fever of 101.2,  chills
This spontaneous report received from a medical assistant referred to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. The medical assistant reported that unspecified patients were administered improperly stored vaccines RECOMBIVAX HB (lot: M020926; expiry date: 11-AUG-2018) on an unspecified date. No adverse effects were reported. The vaccine was stored at 35.52F for 8 hours and 2 minutes. There was no previous temperature excursion and the call was because of digital data logger. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA006359: same reporter.
The symptoms I experienced were not severe nor did they last long. It started with a sore throat then went to a cough and runny nose. I started PAXLOVID and by the time I completed it I was almost symptom free.
It felt as if my anti-psychotic medication, Rexulti, stopped working. I had acute psychosis for which I went to the emergency room and then to the inpatient ward for five days. Increasing the dosage of Rexulti returned me to "normal" .  I had a similar psychosis happen after my second dose of the Moderna vaccine, for which we raised my Rexulti dosage even more, averting having to go to the hospital. Since it happened after each vaccination of Moderna  I believe the vaccine was the cause. There are no obvious other reasons as I had been stable for over four years on this medication.
a 16 years old patient was administered 1st dose of Moderna covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 years old patient was administered 1st dose of Moderna covid-19 vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 years old patient was administered 1st dose of Moderna covid-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 years old patient was administered 1st dose of Moderna covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
My left hip started waking me up with pain, and doctor diagnosed me with bronchitis, Voltaren was recommended (topical NSAID).
lungs filled up with fluids; terrible pain in his back; couldn't lay had to sleep sat down; swelling of his ankles; swelling of his hands; shortness of breath; chills; died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (died) and PULMONARY OEDEMA (lungs filled up with fluids) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Diabetes.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 PULMONARY OEDEMA (lungs filled up with fluids) (seriousness criterion medically significant), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills). The patient died on 01-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PULMONARY OEDEMA (lungs filled up with fluids), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills) outcome was unknown.            No treatment medication was provided.  Patient took concomitant medication for Blood pressure and Diabetes.; Sender's Comments: This is case of death in a 72-year-old male patient with medical history of blood pressure and diabetes who died more than a month after receiving the mRNA-1273 vaccine. Cause of death was not reported. Very limited information regarding the event has been provided at this time.  Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the remaining events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored VAQTA (lot # L036300, expiration date: 04-NOV-2016, route and dose were unknown). The vaccine was excursion to -3.8 degree centigrade for 113 hours. It was not excursion previously. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt got 9 spots on body 14 days after vac was given. Red ring with a white head on the middle.
@ approx 5PM evening of shot pt lt arm became swollen from below shoulder to just above elbow;hard bumps @ inj site;arm painful to touch;taken to ER & instructed to given DPH;some bruising around inj site;
p/vax pt began to exp mild arthritis-type pain localized to hands;p/vax frequency & intensity of pain increased;also began to exp tiredness & pain in wrists & hands is worse when hands are used. Dx of Hashimoto's thryroiditis.
This spontaneous report was received from a nurse and refers to a multiple unspecified patients of unknown age and gender. No information about the patients pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. ON multiple unspecified dates, the patiens were vaccinated with an improperly stored doses of ROTATEQ route defaulted to oral (dose, lot# and expiration date were not reported). No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in left arm, on Sep 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced vaccination site discomfort (his arm has progressively started getting harder and harder to lift), onset Sep 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
FLUSHING, STIFFNESS IN LEFT ARM MOVING UPWARDS TOWARD NECK. NUMBNESS IN THROAT/MOUTH/FACE. ADMINISTERED ORAL DIPHENHYDRAMINE 25MG AND CALLED PT'S PCP. PCP WAS ABLE TO SEE PATIENT IMMEDIATELY AND PATIENT TRANSPORTED TO THE OFFICE (ON-SITE).
Pt developed hives evening of flu vaccine, went to ED, treated with Benadryl and Prednisone.
At 6:30 pm went out to dinner in restaurant.  Felt hot, dizzy and nauseated (did not eat) and vomited once.  Went for check up in ER.  BP normal.  No more problems.
administered a Covid 19 vaccine that was five days over expiration date. She also mentioned that it is in the refrigerator for five days too long.; administered a Covid 19 vaccine that was five days over expiration date. She also mentioned that it is in the refrigerator for five days too long.; administered a Covid 19 vaccine that was five days over expiration date. She also mentioned that it is in the refrigerator for five days too long.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 51-year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 16Nov2021 (Lot number: 30155BA) at the age of 51 years as dose 2 (booster), single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen (Dose 1, Lot: 1808978, Route: IM, R deltoid, No. of previous dose: 0), administration date: 02Apr2021, for COVID-19 immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 16Nov2021, outcome "unknown" and all described as "administered a Covid 19 vaccine that was five days over expiration date. She also mentioned that it is in the refrigerator for five days too long.".  Additional information: It was reported that, they administered a Covid 19 vaccine that was five days over expiration date. She also mentioned that it is in the refrigerator for five days too long. Upon Follow-up (03Feb2022), the Updated information included: "Reporter tab" (Reporter email id and Zip code). "Patient tab" (Patient initial, Age). "RMH" (Prior vaccination). "Product tab" (Administration date, Dose number, anatomical location, route of administration, Vaccination facility details). Relevant Test: List other diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebro-spinal fluid culture, pleural fluid culture, diagnostic imaging, (e.g., chest x-ray, MRH). If COVID-19 testing has been conducted, provide test dates and results. None. Specific relevant test: None. Dose in freezer 5 days too long given to pt. by accident.   Follow-up attempts are completed, and no further information expected.
CHART NOTES FROM 4/23/21 1. Left foot pain    Left foot pain.  Symptoms started with pain to the arch of her foot worse in the morning that are more consistent with plantar fasciitis but now she is having pain on top of her foot.  Possible this nonspecific pain could be related to her polyarthritis.  However to be cautious I do recommend x-ray.  We offered a postop shoe today however when she saw postop shoe she declined.  I do recommend rest and ice.  Orderd: Naproxen 500 mg oral tablet, 1 Tab Tab, PO, BID, PRN, as needed for pain, Qty: 20 Tab,  Foot XR Complete Rt 2. Left leg pain   Patient having some nonspecific pain to the side of her upper calf area.  Given history of DVT to be cautious I do recommend Doppler.  Ordered: US Vasc Dplx Ven Low Ext Rt
Dose arm had big lump of size of small grapefruit or big orange/Had big bump; Super sleepy the day after; Had big bump hot to touch / super-hot; Was hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Dose arm had big lump of size of small grapefruit or big orange/Had big bump), SOMNOLENCE (Super sleepy the day after), VACCINATION SITE WARMTH (Had big bump hot to touch / super-hot) and VACCINATION SITE INDURATION (Was hard) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Patient had a bump and which was hot to touch which looked like insect bite.). Past adverse reactions to the above products included Tiredness with Flu shot.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Dose arm had big lump of size of small grapefruit or big orange/Had big bump), SOMNOLENCE (Super sleepy the day after), VACCINATION SITE WARMTH (Had big bump hot to touch / super-hot) and VACCINATION SITE INDURATION (Was hard). At the time of the report, VACCINATION SITE MASS (Dose arm had big lump of size of small grapefruit or big orange/Had big bump) and SOMNOLENCE (Super sleepy the day after) outcome was unknown and VACCINATION SITE WARMTH (Had big bump hot to touch / super-hot) and VACCINATION SITE INDURATION (Was hard) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant and treatment medications were reported. The patient had big bump hot to touch was hard and lasted for couple of weeks. The day after patient also felt super sleepy.  No treatment information was provided.   This case was linked to MOD-2021-385913 (Patient Link).
5/11 Patient received PCV13 around noon. C/o pain that evening. 5/12 swelling and redness; Fever 102 degrees F. Went to ER. Rx: Cephalexin  tsp po q 8 hrs. 5/13 no improvement increased swelling returned to ER. Rx: Septra. 5/14 Fever decreased lowered swelling and redness. Resolved by 5-17-10.
Localized Rxn to vaccines on (L) arm and (R) arm, redness, hot to the touch swelling and painful.
May 4, developed rash to head and trunk, spreading to extremeties. May 5, temp. 100.0 rectally. May 6, seen in office for evaluation; advised observation, no treatment. May 7 phone call to mother: child acts well, rash persists.
Tenderness turned to moderate pain at injection site. This lasted about 5 days.  Tight chest - resolved in 24 hours. Cardiologist was contacted and spoke to ARNP.  No treatment, monitor condition and call office back or go to ER. Neither was needed.   Large, round, red, warm, itchy welt about 4 inches. Lasted about 14 days diminishing in size and symptoms after 10 days. Initially used Cortisone 10 cream for itching for several days and then switched to Benadryl Cream on day 5 which was very helpful.    Slight tender bump remains under skin at injection site after 14 days.