chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning her 16 year old healthy daughter who received 5 doses of GARDASIL in less than 2 years period. The initial dose of GARDASIL was given 1 and a half years ago (exact date unknown). At this time the patient completed the 3 doses series on schedule. In July 2009, the patient was vaccinated with a fourth dose of GARDASIL. On 25-SEP-2009, the patient was vaccinated with a fifth dose of GARDASIL. There was no concomitant medication. After the fifth vaccination, the patient experienced an injection site reaction. Her arm was hot, red, swollen and painful. She was unable to move her arm. The patient also experienced flu like symptoms including nausea, malaise and severe headache. Unspecified medical attention was sought. The patient slept and did not feel well most of the weekend but felt better on 27-SEP-2009 in the evening. Additional information has been requested.
SORE ARM; FEVER; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included pre diabetic, and pre cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.8 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and fever. This report was non-serious.
Patient went to urgent care due to redness around injection site. Patient was prescribed an antibiotic for possible cellulitis infection.
Anaphylactic allergic reaction- Chest tightness right away, throat tightness, ambu bag with oxygen, tingling, weak, light headed, flushed red and then pale, monitored, Benadryl, Pepcid, and Zyrtec. Assessed by MD on site.
got infected with the Delta variant; got infected with the Delta variant; This is a spontaneous report from a contactable consumer or other non hcp via Contact Center. An 81-years-old patient of an unspecified gender received second dose of 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 an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date was not reported) on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient got infected with the delta variant. Now patient wanted to participate in Pfizer covid booster trial. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Booster; Anaphylactic reaction; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20 year-old female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "Dizzy"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "Dizzy". The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "Anaphylactic reaction"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness". The event "anaphylactic reaction" was evaluated at the emergency room visit. Caller states her daughter experienced an anaphylactic reaction 1 week after the booster dose and had to go to the ER for treatment. Caller does not know the dates for any the Covid shots her daughter received. After each dose of the vaccine, her daughter experienced dizziness within 8-10 minutes. She reports she received a flu shot around the same time and did not experience dizziness.   The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous case reported by a consumer, describes the occurrence of exposure via breast milk (received 1st dose of Moderna vaccine and breastfeeding her 15-month-old daughter) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 006C21A) for COVID-19 immunization. No medical history reported. On Jun 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 2, 2021, patient experienced exposure via breast milk (received 1st dose of Moderna vaccine and breastfeeding her 15-month-old daughter). At the time of the report, exposure via breast milk (received 1st dose of Moderna vaccine and breastfeeding her 15-month-old daughter) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
Tickling of both hand fingers - started 10 days after getting Tdap vaccine. Saw neurologist EMG done - normal.
Intense body aches/body pains after 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (Intense body aches/body pains after 2nd dose) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced MYALGIA (Intense body aches/body pains after 2nd dose).   At the time of the report, MYALGIA (Intense body aches/body pains after 2nd dose) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Ischemic brain stroke with treatment, left side numbness face, arm, and leg.     Emergency Room with admission to local hospital, for 3 days.
12:30 AM - minor headache, body aches, trouble sleeping, pain at injection site 2:30 AM - freezing cold hands, cold feet and body, minor headache, body aches, trouble sleeping, pain at injection site 6:30 AM - minor headache, body aches, trouble sleeping, fainting, pain at injection site
Information has been received from a registered nurse concerning a patient. It was reported that on 10-DEC-2007, while the healthcare worker was administering varicella virus vaccine live (Oka/Merck) to the patient, she was splashed in the eye. It was reported that the patient who was receiving the vaccine did not get the full dose. Medical attention sought was not reported. A product quality complaint was not reported. This is one of two reports from the same source.
Pain and stiffness in lower back lasting 3+ days; swelling of face; took Advil 200mg for pain; cold compresses to face.
was given the invalid ActHIB also asked how many hours is the vaccine viable for use after mixed and drawn up in syringe/ no AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a non-hcp (Office Staff).  This case involves a 4 months old patient who was administered HIB (PRP/T) VACCINE [ACT-HIB] lot UJ176AA (Expiry date unknown) via intramuscular route in the right vastus lateralis, on 12-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE),ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) .   It was an actual medication error case due extra dose administered.   It was reported that child that was given the invalid ActHIB was 4 months old and this was a Well Child Check Up in live follow up reported that She also asked how many hours is the vaccine viable for use after mixed and drawn up in syringe and stored properly in refrigerator?  It was unknown whether the patient had any adverse reactions.  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.  List of documents held by sender: none.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 05-AUG-2013, the patient was inoculated at a pharmacy with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician for a persistent severe vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
pain at injection site; redness at injection site; swelling at injection site; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 19th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling and tiredness. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and tiredness to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient received Shingrix in left arm. The patient experienced pain at injection site, redness at injection site and swelling at injection site. The patient planned to continue follow-up with her physician on an unknown date.  The reporter consented to follow up.
Neurological disorientation such as staggered  motor function. It has been challenging  to walk- extremely noticeable as if you are tipsy on new years eve - Headache in center of forehead that hasn't waned  24-48 hour period of visual abnormalities  Extreme pain at injection site since shot and untol now although getting better  Extreme Lethargy  Shortness of Breath Plugged ears Congestion which went from clear mucus to bright green within an extreme short period of time Dr prescribed augmentin antibiotics  ITS NOT COVID 19 I GOT A NEGATIVE TEST 5/5/2021  All over rolling from extreme to mild pains  Muscle spasms in places all over the body. A part of my body is always twitching under the skin (not any jerking movements others report ) SEVERE CHEST PAIN Swollen arm at injection site  A deep cough not severe and frequent but significant and persistent
pt recv vax; local discomfort & crankiness; observed a 4 1/2 cm area on rt arm over deltoid area; feels warm to touch & slightly raised; pt is alert & is in no apparent distress;
Vaccine was given 12 days after expiration date.  Patient had no issues/problems.
I experienced swelling, body aches, a lot of joint pain and fatigue. I went to the Dr. on June 29th and had my blood drawn and tested for thyroid markers, they all came back negative.
Swelling of the joints after first dose; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of JOINT SWELLING (Swelling of the joints after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Adverse event (no medical history provided).    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 JOINT SWELLING (Swelling of the joints after first dose). The patient was treated with MELOXICAM at an unspecified dose and frequency and METHYLPREDNISOLONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Swelling of the joints after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medication patient is first on treatment meloxicam and her doctor has changed to methylprednisolone but told to wait until 2 weeks before getting vaccine   Reporter did not allow further contact
Numerous episodes of twitching since immunizations. Taken to ER by mom. Reports at 1800 "eyes went up and to the right, turned pale, and was grunting."
Upon awakening and getting ready for work, patient noted rash development on right deltoid extending to upper anterior torso. Patient states that she noted rash continue to spread throughout upper arm and torso, anteriorly and posteriorly over the past week. Patient went to primary healthcare provider on 19 October 2010 for possible urinary tract infection. Patient was prescribed ciprofloxacin 500mg 3 times a day for 5 days and piridium 100mg 2 times a day for two days. Patient states that rash started to itch and feel hot on 19 October 2010 after starting prescribes medications. Patient arrived to flu clinic at Hospital and was referred to occupational health for further evaluation.
Chills, nausea, body pain whole body,, joint sensitivity, loss of appetite, headache.
Patient presented at 1436 with tightness in chest and pain above the L eye. Also reported "dots" in vision. MAE, PEARLLA, 0 CP, 0 SOB. drink was provided, patient declined snack. hx sensitivities to wheat and soy. environmental allergies. 0 DM-- B peripheral artery disease. 0 CVA. hx migraines but years ago. tightness and "dot" resolving after drink provided. initial vitals 96% SP02, HR 68, BP 192/97. symptoms had nearly resolved, feeling better. BP 175/90 and HR 86.
Swelling from injection site to elbow; 12" of swelling, pain and tenderness, hot to touch.
I felt chills although I did not have a fever. I went to bed with chills and no energy and slept for almost 24 hours. I called my doctor to keep her informed. She advised me to come in if symptoms persisted. I also had the expected arm soreness, but the lack of energy was strong. I just could not get out of bed. The next day though, I was able to get out of bed by mid day to eat and move around. After receiving my first dose of Moderna, I began to experience a ringing in my ears that has persisted ever since. I have spoken to my doctor about the ear ringing and am currently being treated for it.
Client reported dizziness in the observation area. The client ambulated and sat down in the anti-gravity chair. The anti-gravity chair was placed into a reclined position. Vitals obtained at 1:55 PM were as follows: BP 134/82, HR 69, O2 98%. The client denied any other symptoms. The client has a history of diabetes and was prescribed Metformin about 2 weeks ago. The client states she has been experiencing dizziness related to the Metformin. She states she did eat this morning, has drank water today, and drank a juice upon arrival at the vaccination site. Offered the client a snack. The client declined. Vitals obtained at 2:04PM were as follows: BP 131/74, HR 71, O2 98%. The client stated the dizziness was getting better. Repeat vitals obtained at 2:14 PM were as follows: BP 129/75, HR 63, O2 100%. The client stated the dizziness is better and rated the dizziness at a 4/10. The client stated her current state was about the same as the dizziness she has been experiencing related to the Metformin. Client was provided education regarding s/s of anaphylaxis and when to seek EMS. Recommended the client follow up with PCP regarding the baseline dizziness. The client voiced understanding of this education. Client ambulated unassisted with a steady gait out of the vaccination site at 2:18 PM.
Information has been received from a nurse practitioner concerning a 26 year old female patient who was vaccinated with the 3 doses of RECOMBIVAX HB (manufacturer unknown) 5-6 years ago and titers were now negative. The patient did respond to the vaccine she got the 3 dose series 5-6 years ago. No further information is available. Additional information has been requested.
Pfizer just got my 5th dose feeling ; Pfizer just got my 5th dose feeling ; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (153987). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 5 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 Immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "Pfizer just got my 5th dose feeling".  Additional information: Patient reported ''Pfizer just got my 5th dose feeling''  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rash; yellow rash; This case was reported by a pharmacist via call center representative and described the occurrence of red rash in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number TB2PK, expiry date 5th October 2021) for prophylaxis.   On 13th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2019, less than a week after receiving Shingrix, the patient experienced skin discoloration. On 17th September 2019, the patient experienced red rash. The patient was treated with avena sativa (Aveeno). On an unknown date, the outcome of the red rash and skin discoloration were not recovered/not resolved.   It was unknown if the reporter considered the red rash and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The patient developed a red rash. He applied Aveeno cream and stated the rash was now yellow in colour. The reporter consented to follow up.
Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 17-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA673A) for prophylaxis.   On 17-JAN-2023, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
came down with COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (came down with COVID) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced COVID-19 (came down with COVID). At the time of the report, COVID-19 (came down with COVID) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
After the vaccine everything was normal, until the next day in the afternoon I felt like discomfort in the barrel of the brazier, when I returned home, I took off my brazier and saw that I had inflammation on the side of my armpit, the same side where I had received the vaccine, I had pain; hard like 2 weeks. I took pain pills and read myself about the symptoms of the vaccine, and since this was one of the symptoms of the vaccine, I decided not to make an appointment with the Doctor.
Patient was waiting after vaccine in 15 minute required post vaccine period and started to become dizzy. She waved us down and we went out to assist her. Patient lost consciousness for about 30 seconds, then regained consciousness with confusion.  We gave the patient water, ibuprofen, and a snack. We had her wait in the pharmacy for 50 minutes after the incident. She was feeling much better upon leaving.
SX: Swollen 2-3" in size, red, hot to touch. TX: Cool compress PRN, Tylenol PRN.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of GARDASIL IM. On an unspecified date the patient had a pelvic exam and it showed that the patient developed "dysplasias". It was unknown if this was after the first, second or third dose. The patient had sought unspecified medical attention. The outcome of the patient's "dysplasias" was not reported. Additional information has been requested.
Approx 80 mm circular area of raised, red and warm to touch. Denies any systemic complaints. Recommended follow up with PCP. Advised to use antihistamine.
3/22/2021 - took double usual dose of hydrocortisone (20mg) prior to receiving vaccine, 7 hours after vaccination - chills, body ache, headache, lethargy. 3/23/2021 - woke with nausea and anorexia, took triple usual hydrocortisone dose (30mg) with yogurt, very lethargic, brain fog with cognitive difficulty, anorexia, stayed in bed all day, eating drinking veyr little.  3/24/2021 - woke with worsening lethargy, generalized weakness, nausea, took hydrocortisone 30mg with yogurt. by noon, very dizzy and weak, unable to get out of bed, friend drove her to Hosp. Emergency Room. Noted hypotension systolic BP 80, clinically dehydrated, Na 129, K 3.2, cr 1.2 (nl 0.97) Diagnosed Adrenal Crisis admitted 3 days to 3/27