chrisvoncsefalvay/vaers-outcomes huggingface dataset:
every dose made her sick; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "every dose made her sick".  Additional information: The patient reported that every dose of the Pfizer COVID-19 vaccine (original primary series and two booster doses) made her sick. She suspected that this reaction was caused by gluten or an egg-derived ingredient. She took a third booster dose from Moderna and that vaccine didn't make her sick at all.  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-202201210013 Same patient/drug/event, different dose;US-PFIZER INC-202201210014 Same patient/drug/event, different dose;US-PFIZER INC-202201210015 Same patient/drug/event, different dose;US-PFIZER INC-202201206422 Same patient/drug/event, different dose;
adult patient received a pediatric dose of Engerix-b instead of an adult dose; adult patient received a pediatric dose of Engerix-b instead of an adult dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 41-year-old female patient who received HBV (Engerix B) (batch number 722KC, expiry date 6th April 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th April 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 30th April 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details was reported as follows: The patient received pediatric Engerix B instead of adult Engerix B, which led to underdose and adult use of a child product. The reporter consented to follow up. No other information was available.
16Apr90 pt vax; 01May90 devel pain at inject site followed by swelling & erythema.  03May90 exp adenitis of right axilla, fever 102F, & joint aches.  Pys exam revealed 2-3 firm, non-fluctuant masses in right upper arm 2cm diameter.
pt devel sensorimotor axonal polyneuropathy, elevated SGPT;necrotizing vascular lesions w/perivascular inflammatory infiltrate;arteriography showed microaneurysms of the kidney, liver & spleen;peripheral quadriplegia,sz;dx periarteritis nod
This case was reported by a pharmacist and described the occurrence of joint pain in adult male subject who was vaccinated with Fluarix for prophylaxis. On 02 November 2006 the subject received unspecified dose of Fluarix. On 04 November 2006, 2 days after vaccination with Fluarix, the subject experienced joint pain, muscle pain, painful skin, respiratory congestion, fever, headache and chest pain. The events were ongoing as of 15 November 2006, but the pharmacist was unsure if the events persisted at the time of initial reporting, 30 November 2006.  Follow-up information received on 02 January 2007 indicated that the events were improved and in the reporter's opinion, the events were not related to treatment with FLUARIX.
Pneumonia; Slept almost all day; Left arm swollen; Hot above the site of injection; Entire body really aching; Redness on the site of injection; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Leukemia in 2011. Concurrent medical conditions included Hearing impaired. Concomitant products included LATANOPROST for Glaucoma, DORZOLAMIDE and VITAMINS NOS from an unknown date to 03-Apr-2021 for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced SOMNOLENCE (Slept almost all day), PERIPHERAL SWELLING (Left arm swollen), VACCINATION SITE WARMTH (Hot above the site of injection), PAIN (Entire body really aching), VACCINATION SITE ERYTHEMA (Redness on the site of injection) and FATIGUE (Tiredness). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia), SOMNOLENCE (Slept almost all day), PERIPHERAL SWELLING (Left arm swollen), VACCINATION SITE WARMTH (Hot above the site of injection), PAIN (Entire body really aching), VACCINATION SITE ERYTHEMA (Redness on the site of injection) and FATIGUE (Tiredness) outcome was unknown.            Treatment for the event included paracetamol. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Induration 11cm left upper arm, redness rash, heat, burning pain left axilla into both legs & settling into both knees. Fever 102.2F 11/11-11/13/11, short of breath 11/12-11/13/11 & resolved within seven days.
Fever to 101 & diffuse macular rash from head to toe eval. Palms/soles.
Site: Pain at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
No known adverse effects; A patient who was born on 20-JAN-2020, was administered the first dose of ROTATEQ on 20-MAY-2020.; This spontaneous report was received from a registered nurse referring to a 4-month-old patient, whose gender was not specified. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided.  On 20-MAY-2020, being 4 months old,  the patient was administered the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally, for prophylaxis. (reported lot number S014947 has been verified to be valid; expiration date was not reported, but upon internal validation it has been established as 10-DEC-2020.) (inappropriate schedule of product administration). There were not known adverse events according to the reporter.
horrible rash; horribly high fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH (horrible rash) and PYREXIA (horribly high fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) at an unspecified dose. On an unknown date, the patient experienced RASH (horrible rash) and PYREXIA (horribly high fever). At the time of the report, RASH (horrible rash) and PYREXIA (horribly high fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.       Breastfed patient got horrible rash and horribly high fever after mother received Moderna Covid Vaccine.  No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Pt recvd vax & exp low grade fevers, skin rashes, swollen glands; No further details were provided;
local abscess @ site of inj-responded (got better) to broad spectrum ATB w/in 18hr;2 doses were used out of this bottle on different pt & both devel infect;
tip of her tongue, lips, and part of cheek close to her mouth went numb; tip of her tongue, lips, and part of cheek close to her mouth went numb; tip of her tongue, lips, and part of cheek close to her mouth went numb; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A 58-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration on Left arm on 03Feb2021 15:59 at single dose for covid-19 immunisation administered at state facility. Medical history included Asthma (diagnosed about 5 or 6 years ago, states she has probably had it all her life) and Fibromyalgia (diagnosed about 20 years ago). Historical vaccine includes Shingrix shot on an unspecified date, she did not feel well for a day, she felt sick but then it resolved it. The patient's concomitant medications includes pregabalin (LYRICA) at 250 mg  (It is a 50mg capsule, she takes 100mg in the morning and 150mg in the evening) for Fibromyalgia; budesonide, formoterol fumarate (SYMBICORT) at 2x/day (two puffs twice a day) for Asthma and montelukast sodium (SINGULAIR) at 20 mg, 1x/day (once a day). The patient reported that she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. 45-60 minutes after, she felt the tip of her tongue, lips and part of her cheek become numb. She said this went away after 30 minutes. Consumer wants to know what reactions can she expect after she receives the 2nd dose, and if it would be worse than her reaction with the 1st dose. Asking if she should take Benadryl before the second dose. She is asking if she would have more of a problem. States she is an allergic person. She stayed at the facility for 30 minutes. Event occurred while she was driving, she thought if it got worse, she would go to the hospital but then it went away. The patient took covid vaccine for preventive action. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The seriousness was reported as non-serious. The outcome of the events resolved.  Information on the lot/batch number has been requested.
Approximately 23 hours after receiving booster vaccine when sitting down my heart rate raced to 120 beats per minute and stayed elevated off and most of the afternoon.  Watch gave me a resting heart rate warning 3 times.
Had complete relief of my chronic back and leg pain for one day. Pain gradually returned in three days.
redness at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 05Mar2021 (Lot number: EM6205) at the age of 77 years 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 Number: 1, Batch/Lot No: EM9810), administration date: 04Feb2021, when the patient was 77 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 2021, outcome "recovered" (2021), described as "redness at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site erythema.  Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient not affected with Covid prior vaccination and tested post vaccination.  No follow-up attempts are possible. No further information is expected.
p/vax pt started having pain & stiffness in wrist & fingers;10/27/99 over the next 2 days knees & ankles were painful & stiff-weakness made it  hard to go up stairs;better today;
PAIN ALL OVER BODY; FATIGUE; DRY COUGH; FEVER; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included no known drug allergies, no significant medical history. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-APR-2021, the subject experienced fever. On 18-APR-2021, the subject experienced dry cough. On 28-APR-2021, the subject experienced pain all over body. On 28-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine  was not applicable. The patient recovered from pain all over body on 2021, and fever on 16-APR-2021, and had not recovered from dry cough, and fatigue. This report was non-serious.
Narrative:  ADMISSION DATE: 09/09/2021 DISCHARGE DATE: 09/13/2021 DISCHARGE TYPE: Regular PRINCIPAL DIAGNOSIS (Reason for admission after study): Hyponatremia: COVID 19: Hyperlipidemia HTN: Leg Cramps AKI: Resolved Anxiety: HISTORY OF PRESENT ILLNESS: pleasant 78 year old male with a past medical history significant for CVA< tremor, HTN and hyperlipidemia. He presented to the ED with complaints of ongoing anorexia, weakness, poor intake, gait instability and overall just not doing well. He had been diagnosed with COVID at outside facility in mid-August ~ 19th. Initially he had been doing okay but over the past 1 week or so he has felt progressively worse. Today he felt so weak he had trouble dressing himself and thus came to the ED for evaluation. Also of note over this same timeline he was started on duloxetine and this was dose was just recently doubled in the past few days as part of the initial upward titration. He has no shortness of breath, he does have some cough, + runny nose. No nausea, no vomiting. Admits to very poor intake. Of note he was fully vaccinated in Feb 2021. HOSPITAL COURSE: He presented to the ED with complaints of ongoing anorexia, weakness, poor intake, gait instability and overall just not doing well. He had a Sodium level of 118 and found to be asymptomatic from COVID. He was treated with IVF and his Sodium rose from 118 to 129. PATIENT has requested to be d/c home today. He will f/up with his PCP to continue to f/up on Sodium level. Duloxetine was stop due to possible side effect with SIADH of his sodium level. Hyponatremia: slowly improving, 127 this morning - ?medication induced SIADH vs hypovolemic hyponatremia - Holding Duloxetine - On IV Fluids, will continue for one more day COVID 19: (+) 9/9/21 - On room air - Supportive care for now Hyperlipidemia - cont. atorvastatin HTN: BP elevated. - Lisinopril 40mg daily continued - Could consider adding Coreg next at low dose for BP control - Elevated currently in the hospital setting, though he has a lot of anxiety Leg Cramp - Dopplers pending to r/o DVT in the setting of COVID - tylenol and or tramadol for pain AKI: Resolved - Admission Cr 1.4, now 1.1 Anxiety: - Restarted home Ativan at 1mg TID as needed
Baby was fussy, cranky for 2 weeks with low grade temp.  Last vaccination of HIB/IPV had no reaction.
Dizziness / Patient has to get up pretty slow due to dizziness; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness / Patient has to get up pretty slow due to dizziness) and VERTIGO (Vertigo) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No relevant medical history provided.     On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DIZZINESS (Dizziness / Patient has to get up pretty slow due to dizziness) and VERTIGO (Vertigo). At the time of the report, DIZZINESS (Dizziness / Patient has to get up pretty slow due to dizziness) and VERTIGO (Vertigo) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment medication included- Vertigo medication
Bivalent vaccine given as second dose. 1st dose 12/6/2022, 2nd dose (Bivalent) 12/30/2022
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been  unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 2 years of age. The patient demographics were updated. On 06-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
I started having symptoms on 5-29-2022 of rhinitis, ride side earache, sore throat, mild cough and fatigue. I took a Covid home test that morning and it was positive. On that same day, I had a telemedicine visit with my PCP office and she prescribed Paxlovid. I began taking the medication that evening. I quarantined until 6-6-2022 and took another home test and it was negative. I am doing great now. I am reporting my breakthrough case of Covid.
13 minutes after vaccine received, during the 15 minutes requested post vaccine, stated "feel whoosy". face flushed at time of statement. BP and HR elevated at time of incident, returned to normal prior to transfer to ED
poss adverse vax rxn-dry cough, elevated temp for 3 days;tine scattered rash p/temp came down-3hr p.vax devel t103;irritabioity & rash that blanched to pressure;itching & vomiting;
Development of vascular lesions and vasculitis as well as numbness to the bilateral 1st and 3rd toes
MODERNA VACCINE DOSE #2 WAS ADMINISTERED TOO EARLY.  ADMINISTERED 19 DAYS AFTER 1ST DOSE (04/01/21).
4x6 in oval red area, warm to touch; soft not tender; increased size over next 24 hr Keflex 500 mg TID given. Then developed urticaria (which he gets chronically at sometimes) ? cellulitis
Flucelvax approved for 18 and older and was administered to 13 year old.
Patient shot burned upon injection and continued to give him pain.  He states that over the next several weeks the pain did not subside and was accompanied by numbness and tingling in the arm.  At one point the pain was significant that he went to the ER for relief.  He has since been seeing his family physician for follow up.  He continues to have pain in the arm.
Pt received vaccination on 8/10/10. Pt reported that she experienced redness, itchiness & hardness at injection site on 8/12/10. She said the hardness had subsided over past 24H. She said she had taken BENADRYL for itchiness. Pt came in on 8/12 & said reaction has subsided.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Swelling and redness at injection site.
Tinnitus began 8 hours after vaccination and has persisted since. Also have muffled sound and sensation of fullness in ears.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On 19-JUN-2015, the patient was vaccinated with an unspecified dose of GARDASIL 9 (dose, route and lot # were unknown) and subsequently and on 05-AUG-2015, the patient was vaccinated with an unspecified dose of GARDASIL (dose, route and lot # were unknown). No adverse experiences and no product quality complaint were reported. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 29-DEC-2017 the patient was vaccinated with one improperly stored dose of VARIVAX (dose, frequency and route of administration were not reported) lot # N014632 and expiration date: 11-MAY-2019). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine was stored in between -14 degrees Celsius (C) to -10 C for 1 hour and 15 minutes and between -9 C to 8 C for 4 hours and 25 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1801USA002606.
After associate received flu vaccine she began driving and suddenly experienced numbness in left upper arm extending to hand and Rt arm. Mouth and teeth also felt numb.
I have been experiencing involuntary shakes,no treatment  and I am still shaking CAT SCAN to see if it might be neurological. They did not see anything with the CAT scan
Patient was brought to me by nurse who was with patient in waiting area when she became anxious after receiving Phizer COVID 19 vaccine. She was alert and oriented when I placed her in the sitting position on an exam table in the observation area. approximately 20 minutes later, she reported feeling itchiness in nose and lips. There was no swelling, redness noted. There was no rash, SOB, difficulty swallowing.  She has taken Benadryl for similar symptoms in the past and requested she be given some. She was given Benadryl 50mg PO. VSS through out. Symptoms resolved over next 20 minutes. She was asymptomatic at 1210 and was discharged with sister to drive home.
I had a bit of pain at the injection site for two days after the injection of 4/7/21 but after few days of no pain the arm started to hurt again and feels a bit swollen since 4/12/21
No adverse events occurred. This Moderna COVID-19 booster vaccine was administered at the correct dosage; however, it administered prior to the 6 months time frame. Patient received two Moderna doses on 5/14/2021 and 6/11/2021. Nurse administering the COVID vaccines was not aware that booster doses needed to be administered 6 months or longer after the 2nd dose of a COVID vaccine.  Patient informed of this error and no adverse effects reported.
Nausea and vomiting within 15 minutes Edema and swelling to bilateral thighs with warmness day 2 L arm pain and swelling with warmness decreased ROM day 1 Neuropathy to entire left side, dragging of left leg day 4 Severe Raspy voice day 3 and 4 symptoms worsen Chest tightness day 3 and 4 symptoms worsen Facial Swelling day 3 and 4 symptoms worsen  Body aches and sweating day 2  Treatments included  Bendaryl 50 mg Phenergan 12.5 mg Acteminophen 650 mg Decadron 4 mg IM
I had a round red rash on the vaccinated site of my skin. It was itchy for one week. I still have the rash.