chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This is a spontaneous report from a contactable nurse via Pfizer-sponsored program. A patient with unspecified age and gender received bnt162b2 (Pfizer Covid-19 Vaccine; Solution for injection; Lot Number and expiration date: not reported), dose 1 on an unspecified route of administration and location on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced shingles after the first dose. The reporter is calling on behalf of the patient, said her patient experienced shingles after the first dose, and she wants to know if it's okay to take the second dose next week. The outcome of the event was unknown.
a red  rash, that started on the injection area and is a constant rash; a rash all the way from her arm to her feet to behind her ears,like wards; arm swell; a red  rash, that started on the injection area and is a constant rash; got a sever allergic reaction; got a rash all the way from her  arm to her feet to behind her ears; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (a red  rash, that started on the injection area and is a constant rash), SKIN PAPILLOMA (a rash all the way from her arm to her feet to behind her ears,like wards), PERIPHERAL SWELLING (arm swell), VACCINATION SITE RASH (a red  rash, that started on the injection area and is a constant rash) and HYPERSENSITIVITY (got a sever allergic reaction) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced RASH ERYTHEMATOUS (a red  rash, that started on the injection area and is a constant rash), SKIN PAPILLOMA (a rash all the way from her arm to her feet to behind her ears,like wards), PERIPHERAL SWELLING (arm swell), VACCINATION SITE RASH (a red  rash, that started on the injection area and is a constant rash), HYPERSENSITIVITY (got a sever allergic reaction) and RASH (got a rash all the way from her  arm to her feet to behind her ears). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 07-Jan-2022, PERIPHERAL SWELLING (arm swell) had resolved. At the time of the report, RASH ERYTHEMATOUS (a red  rash, that started on the injection area and is a constant rash) and VACCINATION SITE RASH (a red  rash, that started on the injection area and is a constant rash) had not resolved and SKIN PAPILLOMA (a rash all the way from her arm to her feet to behind her ears,like wards), HYPERSENSITIVITY (got a sever allergic reaction) and RASH (got a rash all the way from her  arm to her feet to behind her ears) outcome was unknown.            No concomitant medications were reported. Patient was prescribed Steroids, and also to the dermatologist that told them not to take steroids but antibacterial cream and Benadryl, and read that the CDC recommend the EpiPen, and wants to know what could be done.   Reporter did not allow further contact
Swollen, red lesion at injection sight. Lesion measuring about 2-3 inches in diameter.  Lesion painful to the touch but extremely itchy.  Lesion became noticeable about 2 days after injection. Lesion became itchy about 3 days after injection. Lesion beginning to disappear but itchiness remaining at injection sight even on day 6.
Approximately 10 minutes after receiving #3 DTAP and #3 Prevnar shot, patient broke out in pruritic, urticarial rash, is generalized, and respiratory symptoms.
Patient recieved DTaP, MMR, IPV in the left deltoid on 7/28/09 and developed redness, swelling and tenderness from the AC joint to the area just proximal to the elbow.  He had a fever to 102.3 the day following the immunizations.  There were no vesicles. He presented to clinic 7/30 for evaluation. The recommendation was ibuprofen for pain or fever.
Patient developed generalized urticarial rash/hives within 2 hours of receiving Hepatitis B vaccine.
no adverse event; We gave 1 dose of Moderna bivalent to a customer BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 1 dose of Moderna bivalent to a customer BUD) and NO ADVERSE EVENT (no adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 21-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 1 dose of Moderna bivalent to a customer BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 1 dose of Moderna bivalent to a customer BUD) and NO ADVERSE EVENT (no adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 1 dose of Moderna bivalent to a customer BUD).    No concomitant medications were reported.  No treatment medications were reported.
Narrative: Patient tested positive for COVID-19 and was hospitalized despite full vaccination of Pfizer dose 1, 2, 3 (booster), and 4 (2nd booster on 03/02/2022).
presented to the ED 1/5/21 with syncope 1 hour after receiving COVID vaccine found to have acute hypoxic resp failure at rest.  Per family patient's pulse ox low with exertion at baseline for the past couple of months, but she always recovers to above 90%.   She was discharged home with home health with oxygen 1/19/21
11/2/09 - Child received H1N1 monovalent vaccine.  11/3/09 - Parent notified CHN/DOH of rash on all extremities.  CHN referred client to PCP for immediate FU.  No respiratory s/s.  Parent took child to Medical CTR, ER, evening of 11/3/09.  Child treated with BENADRYL, according to parent.  11/04/09 - Hives/rash gone, but reappeared to much lesser degree that evening.
Fever (Tmax: 101.2 F) x 36 hours, treated with acetaminophen with temporary relief. Pain to injection site, ongoing. Nausea, loose stools x 24 hours, resolved without intervention. Day 2 post vaccination: gallstone (presumed) which passed on it's own after 18 hours, acetaminophen taken for pain control. Ongoing: red, raised, irregularly shaped area to right upper arm. Area not at injection site but border within 1 inch of injection site. No itching to area, but painful to palpation. Benadryl taken and hydrocortisone cream applied with no effect. Area continues to grow gradually.
dizziness; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and CHEST PAIN (Chest pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, AMLODIPINE and HYDROCHLOROTHIAZIDE for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DIZZINESS (dizziness) and CHEST PAIN (Chest pain). On 22-Feb-2021, DIZZINESS (dizziness) had resolved. On 25-Feb-2021, CHEST PAIN (Chest pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
After 3-4 minutes of receiving vaccine patient reported of dizziness. When try to help, patient refused any help to be given. Contacted patient's doctor and doctor said they will try to contact patient. Patient was in the store for 20-25 minutes walking around.
Patient was given a dose of Moderna Spikevax vaccine in error as he had previously received a dose of Pfizer vaccine on 9/28/2023 at a different pharmacy.  He has not experienced any side effects of the additional vaccine thus far.
fever, chills, pain, strong headache, joint pain,  uncontrollable shaking, fatigue
There was no adverse reactions reported.  Patient was 14 years old at the time he received the vaccine.  He was monitored for 30 mins.
pt recvd vax & w/in 24hrs pt exp fatigue & h/a;w/in 48hrs exp vomiting,abd cramps,sl elevated white blood cell count;these sx were treated w/oral ibuprofen & phenergan suppository;
1 hour of high-pitched screaming and slight fever. Area of injection of Prevnar was red, swollen and tender. Doctor suspects Prevnar.
I received a BCG shot about 2 decades ago. I have a small scar on my arm from this shot. After the covid vaccine, the scar on that arm got red/swollen. It is the second day and it is still red. I have no redness where the covid vaccine was administered, just redness where the scar from my bcg shot is. Is this sone kind of reaction?
Information has been received from a certified medical assistant concerning a 66 year old female (weight 132#, height 65") with no known drug allergies and a history of faecal incontinence who on 12-DEC-2006 was vaccinated intramuscularly in the left deltoid with a dose of Pneumovax 23 (lot 655290/0959F).  Concomitant therapy included levothyroxine Na, calcium citrate, vitamins (unspecified), ranitidine, ibuprofen, PREMARIN, "hydracil" and "laxative OTC".  On 12-DEC-2006 at 22:00, the patient developed marked redness, pain and streaking in the arm in which she was vaccinated with Pneumovax 23.  The pain radiated to her breast.  The patient had no fever.  The physician advised her to ice the area and prescribed KEFLEX 500 mg and BENADRYL.  On an unspecified date, the patient recovered from the events.  Additional information has been requested.
ALLERGIC REACTION TO SHINGRIX; This non-serious case was reported by a consumer via call center representative and described the occurrence of allergy to vaccine in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergy to vaccine (Verbatim: ALLERGIC REACTION TO SHINGRIX). The outcome of the allergy to vaccine was not reported.   The reporter considered the allergy to vaccine to be possibly related to Shingrix.     The company considered the allergy to vaccine to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2023 The reporter stated his or her mother was currently being sent to the emergency room and they thought it might be the reaction of shingrix vaccine. The patient administered the shingrix vaccine a few days ago. The patient was having an allergic reaction to the vaccine and wanted to know what would be don't to counter act that. The reporter denied the consent to follow up.
Patient explained that 2 days after his ZOSTAVAX vaccination he developed two red rings that formed above his left ankle which had a sensation of nerve pain. He explained that the rings and pain disappeared after approximately 2 weeks. He did not report the adverse event to anyone before today.
Mouth infection; This is a spontaneous report received from Pfizer sponsored program received via contactable consumer or other non- health care professional (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration on 22May2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she got the first COVID 19 vaccine on 22May2021 and she will be getting the second dose on 12Jun2021 upon checking it is 21days apart but she mentioned inside three weeks she developed a mouth infection. The patient wanted to know if it will cause a complication if she has the mouth infection and is taking a disinfection. Therapeutic measures were taken as a result of mouth infection but the infection is not gone yet. The clinical outcome of the event was reported as unknown.  Information on Lot/Batch number was available. Additional information has been requested
This spontaneous report was received from a health care professional refers to a 17 year old male patient. On 10-FEB-2015 the patient was vaccinated with (Oka-Merck) PROQUAD injection (lot # K020753; expiry: 30-APR-2016) (dose, frequency and route unspecified). Concomitant medications were not provided. Nurse stated that the patient received their first dose of MMR II and (Oka/Merck) VARIVAX on 12-JUN-1998. The patient received their second dose of (Oka/Merck) VARIVAX on 12-JUN-1998. The patient received their second dose of MMR II, live on 30-JAN-2002 and their second dose of VARIVAX (Oka/Merck) on 01-AUG-2014. On 10-FEB-2015 the patient was inadvertently administered a PROQUAD (Oka-Merck). No adverse effects reported. No further information provided. Outcome of wrong drug administered was unknown. Additional information has been requested.
Pfizer vaccine. Reactions started the following day. Began with tingling in lips, then tip of tongue. Spread to full tongue and then roof of mouth. Lasted 2 days - took Benadryl. Pain under arm started 5 days after vaccine. Large, painful lump under left armpit. Has lasted 2 days - going to primary care doctor next week for care.
fever; aches; tired; feels cold; injections site soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th January 2020, the patient received the 2nd dose of Shingrix. On 15th January 2020, less than a day after receiving Shingrix, the patient experienced injection site pain (serious criteria clinically significant/intervention required). On 16th January 2020, the patient experienced fever (serious criteria clinically significant/intervention required), pain (serious criteria clinically significant/intervention required), tiredness (serious criteria clinically significant/intervention required) and feeling cold (serious criteria clinically significant/intervention required). The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, fever, pain, tiredness and feeling cold were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, pain, tiredness and feeling cold to be related to Shingrix.  Additional case details were reported as follows: The patient received a dose of Shingrix in right arm. The patient had injection site soreness. The reporter did not consent to follow-up.
On 8/25/04 parents noticed at approximately 9am after awakening that  baby was shuttering  and crying extremely hard.  These symptoms periodically occurred for 1 week and resolved spontaneously. Mom said, baby did not have a fever. Mom said baby was very colicy at that time and they  thought this  was part of the  colic symptoms. They did not seek medical care for symptoms.  No treatment was given. When parents came back into clinic at 6 mos. of age for more immunizations, mom discussed the above symptoms with nurse. Nurse referred them to MD for consult regarding future vaccinations.  MD told mom that baby probably had mild seizures from DTAP vaccine.  He said that baby should not get any more Pertussis vaccine product.  Mom returned to the health department on 11/23/04 for more immunizations and baby received IPV, HEP.B, Prevnar.  No DTAP product was given and baby did not have any adverse reactions.  No VAERS was completed at this time.  When baby came back in on 05/18/05 for his MMR and Varivax vaccine, a VAERS was completed for the problem the baby experienced on 08/25/04.  Nurse advised parent to follow up with MD in regards to receiving DT vaccine at MD's office, because we do not have DT product here at the health department.  Mom agreed to this plan.
injection site got swollen and red for a couple of days; it becomes itchy, dry; injection site got swollen and red for a couple of days; it becomes itchy, dry; This is a spontaneous report from a Pfizer-sponsored program. A contactable female (patient) reported.   A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 11Apr2021 as SINGLE DOSE for covid-19 immunisation.  The patient medical history and medications were not reported.  She got the first dose on 11Apr2021. On an unspecified date, patient experienced the injection site got swollen and red for a couple of days. The mark remained on her arm for two weeks. Now, it became itchy, dry and it looks strange. She was scheduled to get the second dose on 2nd May. She wanted to know about this concern before getting the second dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Dizziness, nausea, fatigue, blurred vision, feeling of forgetfulness. I almost feel like I drank a glass of wine. Just worn out. the first day I had diarrhea.
Shortly after the Pfizer covid 19 vaccine was administered the patient complained of a severe headache.  Her BP was checked and was 206/110 using a wrist monitor... 142/96 using a manual BP apparatus and stethoscope after 30 mins... pt felt chills and was cold.  Complained of nausea 5 mins before EMT arrived.
I had fatigue, soreness in the arm, body aches and chills. These adverse health events lasted for about 3days.
6 month old male patient received Quadracel vaccine, no AE; Initial information was received on 02-Mar-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a six month old male patient who received 0.5 mL first dose DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5656AA and expiry date: 13-Aug-2021) via an intramuscular route in the right thigh for prophylactic vaccination on 10-Feb-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB), INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT), and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation, on 10-Feb-2020.  It was actual medication error case due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
first had the flu which it seem like it lasted for over two weeks; got covid; Initial information received on 27-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves a 74-year-old and unknown gender patient who first had the flu which it seem like it lasted for over two weeks and got covid after receiving vaccines COVID-19 vaccine and influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.     On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer as flu vaccine (influenza immunisation) and all the vaccines of suspect COVID-19 vaccine not produced by Sanofi Pasteur both at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for COVID-19 immunisation.  On an unknown date the patient developed a non-serious first had the flu which it seem like it lasted for over two weeks (influenza) and and then got Covid (COVID-19) (unknown latency) following the administration of influenza vaccine and COVID-19 vaccine. It was reported I'm just now seeing the light at the end of the tunnel it's been a long a weeks.  Relevant laboratory test results included: SARS-CoV-2 test - On an unknown date: [got covid]   Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Recovered / Resolved on an unknown date for the event first had the flu which it seem like it lasted for over two weeks and was Recovering / Resolving for the event got covid.
This spontaneous report as received from a nurse and refers to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported. On 18-JUN-2018, the patient was vaccinated with a dose of PROQUAD (strength, dose, lot #, batch, expiration date not reported) and with a dose of VARIVAX (strength, dose, lot #, batch, expiration date not reported) subcutaneously for prophylaxis. Not known adverse event was reported.
LA c/o pain, redness, swelling, hot to touch. Advised to apply cool compresses to area at give Advil for discomfort.
<5minutes after administration of 2nd Moderna vaccine (1st vaccine was given by us as well with no significant events), patient reported "not feeling well" after standing up and moving from vaccine area. Patients face was flushed, and reported tightness in face and slight in neck area but NO swelling of tongue or trouble with speech. Patient instructed to remain seated and given water. Epipen was not administered as patient was improving quickly and did not want it but it was ready to be administered.  patient was monitored >30minutes and was counseled to take antihistamine Benadryl at home and call 911 if episode worsens/happens again. Parent picked up patient.
PT. C/O RIGHT ARM TENDERNESS, SUBQ NODULE, WARMTH TO SITE, ERYTHEMA, LIMITED R. ARM MOTION, NAUSEA.
Monovalent Covid-19 (Pfizer and Moderna) boosters were administered to 24 patients after agency removed their auhtorization these errors occured from 9/1/22 to 9/7/22. No more monovalent booster vaccines administered after we received the Bivalent Boosters on 9/8/22.  No Adverse event noted. RN
FLU; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza vaccine live reassort 3v), via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST.    On an unknown date, the patient experienced flu (preferred term: Influenza).     It is unknown if any action was taken with Flumist (influenza vaccine live reassort 3v).     The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST  Common Device Name: Nasal Spray  Product Role: Suspect