chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender who on 24-JUN-2015 was vaccinated with a dose of GARDASIL lot # K006960 (dose and route were not provided) which was exposed to temperatures outside of the recommended range during 63 hours excursion (incorrect product storage). No adverse effects had been observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding patient's pertinent medical history, concomitant medications, concurrent conditions, drug reactions, or allergies was provided. On 28-OCT-2016, the patient was vaccinate with expired dose of ROTATEQ, oral liquid (dose was not provided; lot # K019372, expiration date: 16-JUL-2016). No adverse events were reported. Additional information has been requested.
pt recvd vax & exp pain for next four days; pt devel a raised, red welt & swelling @ the inject site; swelling began to subside by Wednesday though some warmth & swelling remained;
developed the exact same rash as her husband; This spontaneous case was reported by a consumer and describes the occurrence of RASH (developed the exact same rash as her husband) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (developed the exact same rash as her husband). At the time of the report, RASH (developed the exact same rash as her husband) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2022-502854 (Patient Link).
Low grade fever, widespread muscle pain (#8 on pain chart) severe headache, mild nausea, fatigue, swollen , painfull glands in neck, soreness at site of injection that traveled into armpit,
Fever of 102.8 for the first three nights after the injection, muscle soreness on left arm for three days after the injection, and night sweats for three nights after the injection. In addition to adverse events there was also body aches, joint pain in knees and wrists, tingling sensation in toes and fingers, fatigue, slightly blurred vision, and a persistent headache and dizziness. All symptoms lasted for the first three days and nights after injection. On the fourth day, however, the tingling in the fingers and toes, body aches, and severe dizziness and headache (that impairs daily life functions) have persisted to this day without any relief. In addition to that, I am having trouble remembering day to day functions and past events.
got so sick; Initial information was received on 06-Dec-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves patient who experienced got so sick (illness), after receiving vaccine INFLUENZA VACCINE  Relevant medical history, concomitant medications and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious got so sick (illness), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was illness.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.
After the first injection, left arm was very painful and continued even up to the 2nd injection. I decided to get the 2nd injection in the same arm because I didn't want both arms hurting like this. The second injection was given on 4/29/21. It was Moderna, Lot # ER8735 At that time the arm got worse. It was achy and warm all the time. At some point the pain moved up my arm and into my shoulder. I got to where it was difficult to use that arm in certain tasks like putting seatbelt on, putting hand on hip, crossing arms in front to pull off shirt, unfastening bra behind me, etc
fever up to 105º 24 hr; 99º-101º for the next 24 hr. Severe muscle pain and headache 48 hr.
pt recv vax 3PM starting @ 6PM whole lt side of body from top head to waist felt very tender to touch, ached when not touched;felt nauseous & tired since 6PM;10SEP96 rt side of upper body shoulder neck feels kind of numb;pain;neck stiff;
Patient contacted pharmacy at 3:15 PM and told the pharmacist she had a fainting spell approx. 1hour after receiving Zostavax vaccine.  She said she felt better but wanted to report the adverse reaction
she was set back and was sick as a dog for 3-4 days; This is a spontaneous report from a contactable consumer. A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on Feb2021, as dose 1, single for COVID-19 immunisation. The patient's medical history included COVID on an unspecified date in Jan2021, to which she had terrible indigestion and was hospitalized to the hospital for 8 days. Patient's oxygen levels were 91-92, in which she would occasionally get some oxygen to help her breathe. She had tests done for 4 days in the hospital, after which she was discharged upon recovery. Concomitant medications were not reported. The patient's doctor advised to get vaccinated within 3 weeks after recovering from COVID, to which the patient opted for 4 weeks after because she felt it was too soon. Patient was healthy after her recovery. On an unspecified date in Feb2021, after the administration of first dose of vaccine, the patient was set back and was sick as a dog for 3-4 days. Patient recovered from it, but has yet to receive her 2nd dose. Patient was not sure how she could receive it and she believes she has enough antibodies and asked about any test to determine how many antibodies she took and what was the value she was looking for. The patient underwent lab tests and procedures which included oxygen consumption: 91-92 during COVID infection, on Feb2021. The clinical outcome of the event was resolved, on an unspecified date in Feb2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not provided. On 28-FEB-2019, the patient was vaccinated with GARDASIL 9 (Lot # N017686, expiration date 02-FEB-2020) (strength, dose and frequency were not provided) via intramuscular route for prophylaxis following a temperature excursion. No adverse effects were reported in the patient. The GARDASIL 9 was stored at a temperature of 47.7 degree Fahrenheit, for a time frame of 25 days and there was no previous temperature excursion. Digital data logger was involved. There was no PQC involvement.
This spontaneous report was received from a pharmacist, referring to an approximately 69 year old female patient. Patient was allergic had an anaphylactic reaction to penicillin (on an unspecified date). On 14-APR-2008, the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, route, lot # and expiration date were not reported). Concomitant therapies included estrogens (unspecified). On an unknown date, the reporter stated that the patient experienced shingles about "4-5 times" since receiving the ZOSTAVAX. The patient saw the physician for medical attention (unspecified date), none lab diagnostics studies were performed, but the patient was treated with acyclovir. The pharmacist reported patient currently had an active case of shingles. At the time of the report, the outcome of shingles was reported as not recovered/not resolved. No product quality complaints were reported. Additional information has been requested.
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old patient who was vaccinated with a 0.5 ml dose of ACT-HIB lot UI861AAB, 2 Feb 2019 via intramuscular route in the right thigh on 29-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique as patient was administered ACTHIB but it was reconstituted with sterile water instead of 0.4% saline diluent. It was not reported whether the patient experienced any adverse events following the vaccination. The patient had a visit to the doctor on 29-Oct-2018. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.
Headache, Myalgia, Arthralgia, Fever,  chills Narrative:
Swelling and pain at the site (left deltoid), swelling in the left axilla. Persisted x 3 weeks before resolving slowly.
Dizziness, Headache, Fever, Diarrhea, NauseaVomiting, Tachycardia, injection site pain, chills, fatigue Narrative: Employee reportedly experienced dizziness and tachycardia (no values provided) within 15 minutes of receiving vaccine. Also reported injection site pain/discomfort/swelling, fever (99.4), chills, headache, fatigue, and nausea/vomiting/diarrhea. Employee was excused from work for the next day. Reports took Tylenol, ibuprofen, and Xanax (no dose or frequency information reported).
Approximately 2-3 days after second dose of Moderna vaccine, I developed severe stomach pain.   I thought I was just having an attack of some sort and that it would pass; sadly it did not, so I scheduled an appointment with the doctor. On 6/23/2021  I saw Dr. who prescribed Protonix and scheduled lab work.  On 7/8/2021, I was advised my lab work indicated hyperthyroidism.  Subsequent tests indicated Graves disease.
Pt reports received ZOSTAVAX and hepatitis B #2 in left arm 4D ago. Awoke last night with stinging pain and itch underside left upper arm. This AM noticed rash. Other Sx-low energy today and "funny feeling" left side of neck X several hours. Denies fever, rash elsewhere, arthralgias, URI sx or GI sx. Meds ZOCOR, bupropion, ZOLOFT, ALBUTEROL inhaler, vitamins, calcium and PREMARIN cream. Allergies-Multiple see list. Varicella zoster titer positive last month. No prior hx zoster. Not immunocompromised. On exam pleasant well nourished, well developed 60 yo female in NAD. Skin-papular vesicular rash over left upper arm lateral underside, along C-2 dermatone. A: zoster like rash 4D after ZOSTAVAX vaccine: Dr consulted and saw pt. review up to date zoster vaccine- <1% post marketing reports herpes zoster. Rx- VALTREX. Discussed med. how to take and side effects. Counseled RE: illness, course and treatment. Followup with primary provider sx persist or call back sooner sx increase
having her go in for IV hydration; This is a spontaneous report from a non-contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in February2021, the patient was going in for iv hydration. Therapeutic measures were taken for the adverse event. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Within 1 hour of vaccine, she got tongue numbness, throat itching. It lasted a couple of hours. Recurred with second dose but not as severe.
This is a spontaneous report from a contactable consumer (patient mother) via a non-clinical study program. This consumer reported similar events for 2 patients. This is the 2nd of 2 reports. A 19 years old male patient of an unspecified age and ethnicity received the first dose of TRUMENBA Lot number and Expiration Date: J28923, JUN2016, in the arm at 0.5 ml single on 20JUN2015. The patient was not taking any other medications and was not having any other medical conditions. On 21JUN2015, the patient experienced swelling and tenderness of lymph node  under arm where vaccine was given. The events were described as tenderness at the injection site, glands at the injection site swelling under the arm. The events had resolved. The patient's brother reported the same events after administration of the same vaccine (first dose). The patient did not undergo any lab work. No doctor was consulted. The reported stated that she decided to give ADVIL because of the tenderness at the injection site. Follow-up (22JUN2015): New information from a contactable consumer via a non-clinical study program, includes: patient age, ethnicity, height, weight, vaccination date, events details, onset date, outcome, treatment received. Follow-up (16JUL2015): New from a contactable consumer: This Consumer reported in response to the Non HCP letter sent which includes: Lot Number and Expiration Date, onset date and outcome. Follow-up (16JUL2015): This follow up report contains no new safety information.
This spontaneous report was received from a physician via company representative refers to an unspecified child female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. It was reported that unspecified mother of a child stated to the physician that she did not want to give her child the GARDASIL, because her friends neighbor's daughter was vaccinated (date unspecified) with the dose of GARDASIL injection (dose, route of administration, lot# and expiration date were not reported) and became paraplegic (details unspecified). The physician said the mother informed him that this was described in the newspapers (unspecified). The outcome of the adverse event and the causality between the adverse event and GARDASIL were not provided. Upon internal review, paraplegia was considered to be disabling. Is not expected as there was no consent for the follow-up.
onset 11/18/04 am complaint of not feeling good. Checked her arm where she received the vaccine had redness . No hives. Pt came in clinic and her right deltoid has redness and wheal 2 cm in diameter and has 2 tiny spot on her left arm. No other symptoms feeling fine today. Told MOC to observe if the wheal got worse or has more spots to keep her home and let us know. 10/24/04: rash was gone and feeling fine.
Received vaccine and observed without incident. Pt was seen attempting to enter his car and was disoriented and unable to open the door. Per report, he also had expressive aphasia at that time. An ambulance was called and patient was transported to local hospital for further evaluation.
Information has been received from a medical assistant referring to a 13 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 16-JUN-2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot # M036059, expiration date 03-JUN-2019) (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012776: US-009507513-1709USA012777: US-009507513-1709USA012774: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733.
On 12/20/2022, I woke up and I didn't feel well. I felt cold like symptoms coming on. My wife had already woken up and was downstairs. We are both very worried about COVID-19, so before coming downstairs, I took a COVID-19 test and it was positive. I informed her from a distance about my results and then immediately started quarantining. I made an appointment for a consultation with my doctor and got in touch with her a few hours later. She prescribed Paxlovid, so my wife went to get that for me. I took it as prescribed. For the most part, the Paxlovid really helped. The doctor did warn me that I might "rebound." The COVID-19 wasn't terrible. My fever never got that high. It never got any higher than the first day I checked it. On 12/25/2022, it had been five days and I ended quarantine. On 12/29/2022, around mid-morning, I was sneezing, and my wife suggested I take a COVID-19 test. That test was positive, but I had heard that you can test positive for a while after having COVID-19. I took my temperature, and it was around 100.4 and I normally run around 97.6. I treated it with Tylenol as I did before. I did a video consolation with a doctor in my primary care physician's medical group. They suggested that I quarantine again because it sounded like a rebound case. I never loss my sense of taste or smell the first time I had COVID-19. The second time, I did lose both on the third night. That lasted for around 5 or 6 days before it returned. On the rebound case, I had more chills and flu like symptoms at the beginning and all I was taking was Tylenol. After a few days, my flu like symptoms got better. I ended my quarantine after five days.
20 hrs. long stomachache; unable consume food; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4; Manufacturer unknown), for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 30Dec2022, outcome "recovered" (Dec2022), described as "20 hrs long stomach ache"; FEEDING DISORDER (non-serious) with onset 30Dec2022, outcome "recovered" (31Dec2022), described as "unable consume food".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Bleeding from vagina. Started about 72 hours after vaccine. Heavy bleeding for 2 weeks, continued spotting. I am 57 years old and past menopause.
Covid positive; Covid positive; This is a spontaneous report received from a contactable reporter (Other HCP) from medical information team.  A 10-year-old male patient received bnt162b2 (COMIRNATY), administration date 10Nov2021 (Batch/Lot number: unknown, expiration date unknown) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Nov2021, outcome "unknown" and all described as "Covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Nov2021) positive.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events Drug ineffective, Covid-19 and suspect drug BNT162B2 cannot be excluded.
Extra dose of DTaP/IPV and MMR/V given.  Child was here for 4 yo WCC but clinic did not realize she had come in January for a nurse visit for the same vaccines.  No adverse symptoms noted at this time.  Mom informed once duplication error was noted (soon after admin).
Minor rash around injection site approximately 3-5 cm, rash appearing lower in the arm suggesting incorrect administration (subcutaneous) lower than the deltoid muscle. Patient stated vaccine was administered lower than the deltoid. Patient treating rash with OTC cream and will follow-up if any changes. Pharmacist scheduled follow-up for next day. Today 05/05 patient returned to pharmacy to show rash and question revaccination. Providing administration errors revaccination guidance documentations for recommendations in case of subcutaneous administration to patient for guidance.
3 hours post vax, the pt experienced chills, shakes, general feeling of being real sick with the flu. 1 year later, the pt experienced morning sickness, soreness, headaches and fatigue.
Three months after I received my booster I developed COVID-19. I was immediately put on a breathing machine, using Mucinex, Tylenol/Ibuprofen regime for my fever, by day 17 I was put on prednisone for an ear and respiratory infection. Breathing and asthma are worse my oxygen levels are in the low 90's, my doctor is trying to work on getting that back up.
No additional AE; A patient received a inadvertent administration of an expired dose of PNEUMOVAX 23; This spontaneous report was received from a nurse and refers to a 56-year-old patient of an unknown gender. The patient's pertinent medical history, concomitant medications, concurrent conditions and drug reactions/allergies were not reported.  On 07-SEP-2023, the patient was inadvertent vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection, vial, 0.5 milliliter, lot number: U025499 with expiry date reported as 07-AUG-2023, (route of administration and anatomical location were not provided) as prophylaxis. No additional adverse events (AEs) reported.
Patient developed a fever, body aches, chills, palpitations, dizziness and fatigue that lasted for 10 days past the second dose of the moderna vaccine Three days before being seen at Medical Center for her long lasting vaccine side effects, patient states that she took 50mg of benadryl twice a day to see if it would help with her body aches and palpitations.  This probably made her symptoms worse with the increased sedation from the benadryl.  Blood work and Ekg were done.  EKG was read as normal. Her cbc showed an elevated WBC and platelet count.  Her chemistry panel was unremarkable.  She was told to stop taking benadryl, increase fluid intake and monitor her temperature. The patient was seen in followup and felt better with resolution of her symptoms. CBC was repeated twice and the last one done on June 7th showed that the wbc was normal and her platelets were coming down (only slightly above normal).  Patient has fully recovered.