chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 16-FEB-2017, the patient was vaccinated with an expired dose of PROQUAD with lot # L014405 and expiration date on 30-OCT-2016 (anatomical route of vaccination was not provided) for prophylaxis. Furthermore, it was reported that on adverse effect were suffered and that no product quality issue was involved. Additional information has been requested.
prevnar and fluzone hd given in each arm at same day sept 19th. patient called on sept 24th stating swollen and painful right arm starting tuesday sept 22nd and it is getting worse per patient.
PAINFUL KNOT ON HAND; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included intermittent chest pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prevention of covid-19. No concomitant medications were reported. On 27-MAR-2021, the subject experienced painful knot on hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful knot on hand. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sweating; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweating). At the time of the report, HYPERHIDROSIS (Sweating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported.  Treatment information was not provided.
pt recv vax & the following day devel hives on upper chest & erythematous nodule on arm, just below inj site;
c/o fatigue, body aches, chills, night sweats and sore throat. fever spiked at 104F 3 days later. diagnosed w/ strep throat 11/8/2021
Can only taste sweet and salty; Can't smell; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 84 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/lot number: FF25872), administration date: 29Sep2021, when the patient was 83-year-old, for COVID-19 immunization, reaction(s): "Fatigue"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: TASTE DISORDER (non-serious) with onset 2022, outcome "not recovered", described as "Can only taste sweet and salty"; ANOSMIA (non-serious) with onset 2022, outcome "not recovered", described as "Can't smell"; FATIGUE (non-serious) with onset 2022, outcome "recovering". Additional information: Can only taste sweet and salty: Start Date: Didn't pay any attention to it. Clarified that food isn't her favorite thing, eats for nourishment, then realized she could only taste sweet. Can't taste chocolate and that is serious. Started sometime after the last booster, the fourth shot in the series.  Recognized she wasn't tasting but ignored it because she thought it was something else. Then a month later realized she couldn't smell anything while going to the bathroom. Outcome: Ongoing and has gotten worse, can't taste chocolate.  Can't smell: Start Date: About the same time as she noticed she was not able to taste anything. Can't smell when she is in the bathroom and doesn't have to open windows. Read some material when she got her vaccinations and realized it was dangerous because she can't smell smoke or gas which is dangerous. Testing: Hasn't mentioned her side effects to her HCP because she was dealing with other things. Has an appointment next month. She is an old lady and doesn't have energy to deal with a bunch of things at once. Doesn't have energy: Thinks at 85 she doesn't have the energy like when she was younger. Clarified she doesn't have as much energy due to her age which started before receiving the Pfizer COVID-19 vaccines and the fatigue was different and the fatigue started after receiving the Pfizer COVID-19 vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300070379 Same patient/product; different dose/events;
Severe joint aches set in on day 3 after the flu shot.  I felt like I had sudden onset arthritis.  It lasted about 3 weeks and it was really bad. I had a similar reaction to a DTAP several years ago but I have had the flu shot often since and never had this happen.  In addition, my mother got this same vaccine and had the same aching joints and both her shoulders hurt badly as well as her hips for more than 2 weeks.  She felt physically ill after the quad vaccine.
shortage that occurred; This case was reported by a other health professional via call center representative and described the occurrence of product supply issue in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, many patients who were late for the 2nd dose due to the shortage that occurred, which led to product supply issue. The reporter did not consent to follow up.
Patient reported noticing soreness the evening after the shot. In the morning she noticed a raised red area. Marked borders with pen, it was expanding throughout the course of 10-31. It was itching and hot. No treatment yet. I advised her to inform her doctor. She has an appointment for unrelated reasons tomorrow, she will discuss treatments with her doctor tomorrow.
Pt reports arm was swollen, red, fever,chills from shoulder to hand- pt applied cold compresses and took Tylenol.
shingles; This non-serious case was reported by a consumer and described the occurrence of shingles in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included atrial fibrillation. Concomitant products included nebivolol hydrochloride (Bystolic).   On 25-MAR-2023, the patient received Shingrix. On 28-MAR-2023, 3 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt date:30-MAR-2023. This report was submitted via the online direct entry reporting system. Patient stated that symptoms were treated. The reporter requesting consent to follow up.
Administration vaccine error.  It is suspected that a 1/2"needle syringe was used instead of a 1" needle syringe.
Patient received Pfizer COVID vaccine on 1/23/21 (lot # EL3302), 2/12/21 (lot # EL3302), and 10/1/21 (lot # EW0186). On 1/26/22, patient admitted to our inpatient facility with acute hypoxic respiratory failure and viral sepsis secondary to COVID19 pneumonia. As of today (1/27/22), patient is still admitted in the med/surg unit.
Around 12pm, we get home and, after a bath, I put her clothes back on and she starts screaming. I take her clothes off and her left leg is beet red, somewhat swollen and her torso and right leg are blotchy. She screamed for about thirty minutes and I gave her Motrin and 1/2 tsp Benedryl
Information has been received from a registered nurse concerning a 1 year old child with streptococcal pharyngitis who on 03/31/2000 was vaccinated with varicella vaccine. Concomitant therapy included (therapy unspecified). On 05/10/2001, the pt experienced lesions on trunk minimal and strep phyaryngitis and went to the doctor's office. Additional info has been requested.
This spontaneous report as received from a medical assistant refers to a male patient of unknown age. The patient was vaccinated with VARIVAX (Merck) in 2008. No other co-suspects were reported. No concomitant medications were reported. In 2008 the patient was administered two doses of VARIVAX seven weeks apart. On an unknown date the patient experienced titers are too low. No treatment information was reported. The outcome of administered two doses of VARIVAX seven weeks apart is unknown. The outcome of titer too low was reported as not recovered/not resolved. Administered two doses of VARIVAX seven weeks apart is not related to VARIVAX (Merck). The relatedness for titer too low is unknown for VARIVAX (Merck). Additional information has been requested.
This is a spontaneous report from a noncontactable consumer (patient). A 41-year-old (non-pregnant) female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 41, via an unspecified route of administration, on Apr 6, 2021, at 09:00, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 6, 2021, at 19:00, patient experienced diarrhea that has not subsided yet. The event did not result in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. No therapeutic measures taken as a result of events. Since the vaccination, patient has not tested for COVID-19. The outcome of diarrhea: not recovered (at the time of this report). No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Swelling, redness, hot to the touch, to (R) leg. Measuring 6"x5". Feeling itchy 2 days after immunizations were given. Tx: KEFLEX, BENADRYL, PRELONE, ibuprofen.
p/6 doses of vax pt lab eval revealed a lack of response;pt exp flu like sx, congestion, dizziness, nausea, & extreme fatigue;pt exp inability to hear in lt ear upon waking up;seen by MD;MD saw nothing w/ear canal;canal not blocked;60 day follow-up / no additional data.
Mother called on 8/15/00 and stated that the pt developed a bump, red rash on left leg. No fever, no fussiness and normal activity.
Had allergic responses to both shots given; So far 2nd shot is only hurting at injection site and joint pain.; So far 2nd shot is only hurting at injection site and joint pain.; This is a spontaneous report from a contactable consumer or other non hcp. A 34-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8729 and Expiration date was not reported), via intramuscular route of administration, in Arm Right, on 09Apr2021 at 18:00 (at the age of 34 years) as a single dose for covid-19 immunisation. The patient medical history included allergy that induce asthma from an unknown date and unknown if ongoing, cholecystectomy from 2003 to an unknown date, appendix removed from 2004 to an unknown date, ongoing acid reflux slow emptying Onset age:12 Emptying test: 2000, tooth pain from an unknown date and unknown if ongoing, vaccine reaction, environmental drug allergies and food from an unknown date and unknown if ongoing (Allergic shot to 1997to2000+ prescribe treatment of meds), colon polyps from 2015 to an unknown date Surgery colonoscopy's and no gallbladder. Known allergies included shellfish, leviquinn, augmentine, environmental allergies. Concomitant medications included ibuprofen taken for toothache, loratadine (CLARITINE ALLERGY); diphenhydramine hydrochloride (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) taken for reaction to preservatives from 09Apr2021 to an unspecified stop date; cetirizine hydrochloride (ALEGRA) taken for reaction to preservatives from an unspecified start date and ongoing; montelukast sodium (SINGULAIR). The patient previously took Levaquin for hypersensitivity, augmentine [amoxicillin sodium; clavulanate potassium] for hypersensitivity. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EN6284 and Expiration date was not reported), via intramuscular route of administration, in arm left, on 17Mar2021 at 5:30 PM, as a single dose for covid-19 immunisation and experienced puffy eyes, turned red all over, sore throat, itchy skin random spots, Ears clogging and swollen glands. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior vaccination patient had no COVID. Since the vaccination, patient has not been tested for COVID-19. On 09Apr2021, the patient had experienced only hurting at injection site and joint pain; On an unknown date, had allergic responses to both shots given. Patient was received treatment for events. Treatments include Benadryl 2 after shot stayed 30 min and Benadryl 4 pills+ inhaler 2 before 2 after stayed 40min. Doctor on site advised Benadryl and monitored patient. No relevant lab test was performed. The clinical outcome of all events was recovered on an unspecified date in 2021. The seriousness was reported as non-serious.  Follow-up attempts are completed. No further information is expected.
One day post vaccination the injection site was erythemtous and indurated. Pt a little fussy. On exam an8X9 area of induration and erythema.  Site was non tender. No drainage. No fever. Treated symptomatically.
Since I got the shot I have been tired. I haven't been able to walk like I used to, I used to do 10k steps now I barely can hit 3k before the pain of my arthritis is to heavy. My sugar all of the sudden spikes up and down, I have headaches, I have muscle aches, and weight gain.
I noticed this weird bruise where I got my vaccine and I felt stomach pains and lack of an appetite afterwards.
Muscle appears to be a little swollen at injection site; Eczema-like reaction - patchy like; Slightly tender; Red; Lymphadenopathy, slightly tender and red; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ECZEMA (Eczema-like reaction - patchy like), TENDERNESS (Slightly tender), VACCINATION SITE ERYTHEMA (Red), MUSCLE SWELLING (Muscle appears to be a little swollen at injection site) and LYMPHADENOPATHY (Lymphadenopathy, slightly tender and red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced TENDERNESS (Slightly tender), VACCINATION SITE ERYTHEMA (Red) and LYMPHADENOPATHY (Lymphadenopathy, slightly tender and red). On 07-Jan-2021, the patient experienced ECZEMA (Eczema-like reaction - patchy like). On 08-Jan-2021, the patient experienced MUSCLE SWELLING (Muscle appears to be a little swollen at injection site). On 08-Jan-2021, ECZEMA (Eczema-like reaction - patchy like) had resolved. At the time of the report, TENDERNESS (Slightly tender), MUSCLE SWELLING (Muscle appears to be a little swollen at injection site) and LYMPHADENOPATHY (Lymphadenopathy, slightly tender and red) outcome was unknown and VACCINATION SITE ERYTHEMA (Red) had not resolved.        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.   No relevant concomitant medications were reported.  No treatment details was reported.; Sender's Comments: This case concerns a female who experienced events of unexpected eczema, tenderness and expected vaccination site erythema, muscle swelling, lymphadenopathy.  Event onset occurred 7 days after the first dose of mRNA-1273. Treated with diphenhydramine. Events resolved or resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt recv vax on 3/30/99; on 4/9/99 pt exp headache, myalgia, arthralgia, rash on entire body, swollen/ tender submandibular nodes, sore throat
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-393302, MOD-2021-393303 (Patient Link).
Extreme headache, full body ache, chills, sore throat, and fatigue.
on 11/5/21 I went to push in the plunger to administer the vaccine, the vaccine gushed out of the syringe instead of going into the patient. I wasn't sure what to do at the time, so I let the patient go so I could contact my clinical pharmacist specialist and also call Janssen. They advised me to administer the vaccine again, but the patient had already left. I called him to come back, and he was not able to come back that day. So I reached out again to Janssen and our clinical specialist to see if I should just administer it as soon as possible. Janssen could not give me that information, but my clinical specialist advised that if an unknown amount was administered, it should be repeated. I called the patient on 11/10/21 to come back in, and he finally came back on 11/16/21 for his repeat dose.
Headache, Myalgia, Fever, NauseaVomiting, chills, fatigue Narrative:   Other Relevant History:
Received Tdap 07-08-2010. Client stated pain started the day after receiving shot-continue to hurt everyday and began swelling on 07-13-2010-with redness on 07-15-2010. Came to HD today. Pain under arm. T-98.6. Reddened area 4 x 4 in at and below injection site and warm to touch. Client referred to MD for evaluation client also instructed to apply ice packs and take MOTRIN to reduce swelling.
Probably Guillain-Barre Syndrome (polyneuropathy similar to GBS that occurred in 1981); Probably Guillain-Barre Syndrome (polyneuropathy similar to GBS that occurred in 1981); Probably Guillain-Barre Syndrome (polyneuropathy similar to GBS that occurred in 1981); This is a spontaneous report from a contactable other hcp (patient). A 67-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0164), via an unspecified route of administration, administered in Arm Left on 20Aug2021 08:15 as dose 1, single for covid-19 immunisation.  Medical history included thyroid cancer from an unknown date and unknown if ongoing, allergy to arthropod sting from an unknown date and unknown if ongoing bee stings, polyneuropathy similar to GBS that occurred in 1981. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; vitamin d [vitamin d nos) taken for an unspecified indication, start and stop date were not reported; ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Aug2021, the patient experienced probably guillain-barre syndrome (polyneuropathy similar to gbs that occurred in 1981). The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was taken as a result of events. The outcome of the events was not recovered.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Guillain-Barre syndrome, Polyneuropathy and condition aggravated cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. 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.
This case was reported by a physician via sales rep and described the occurrence of injection site pain in an unspecified number of patients who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not applicable for this report. The physician mentioned generally that, the only adverse event she had really observed with BEXSERO was injection site pain.