chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a 77 year old male patient with hypertension and spinal stenosis refers to himself. On 05-APR-2014 the patient was vaccinated with a dose of ZOSTAVAX, lot # J013449, expire date 24-JAN-2015, 1 injection , (route unspecified). Concomitant therapies included metformin hydrochloride, omeprazole (manufacturer unknown), amlodipine, bisoprolol fumarate, ZIAC, FLONASE, and FLOMAX. ON 30-JUL-2014 (also reported as mid to early July) the patient experienced a steady annoying pains both night and day that did not go away located on his lower left ribcage. His symptoms increased in intensity throughout 09-SEP-2014 and were so persistent that he went to the Emergency to seek medical attention. The treating Emergency Room physician did not rule out a case of shingles; however, the patient did not have a rash at or around the area causing his pain. The primary physician of the patient could not diagnose the patient with shingles and was referring him to a neurologist (unknown name and demographics). No treatment was given for the event. The outcome of the event was unknown. Additional information has been requested.
noted increased BP for 36 hours after vaccine.  162/86, 161/84, 152/79.
Head ache and fever.  Also had a rash on my torso, but I believe that was related to fever as that is the normal reaction I typically have when I have a fever.  Head ache and fever resolved after approximately 48 hours after onset.
got flu; Initial information received on 15-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced got flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any concomitant disease or risk factor.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, lot number, expiry date, route, administration site: not reported) as Flu shot (Influenza immunisation).  On an unknown date the patient got flu (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event got flu.
Patient received a 2nd booster of Pfizer FK9896 Covid vaccine on 4/5/2022. However, it was discovered after patient had received the vaccine shot that he was two weeks early to the allowed time frame (four months after first booster shot). The patient's first booster shot was 12/18/2021 and he would not have been allowed to receive the second booster until 4/18/2022, but received it early, 4/5/2022. Patient did not demonstrate or state any adverse effects during the 15 minute observation post vaccination.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 08-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
poss SIDS brought to hosp 12nppn 31OCT93; DOA no prev s/s; mom put pt to bed that AM checked noon not breathing;
Pt s/p having stepped on a nail. Pt had no insurance and was sent from MD office with script for Tdap vaccine to public health on 5/28/08. Pt stated she thought she might have had a Td vaccine "a couple of years ago, but not sure". Stated she had told M.D. this and they still wanted her to get the Tdap vaccine that day. Pt called later in evening to Public Health on-call nurse to state her upper arm was red and "swollen to twice it's normal size" and pt had tingling in fingers. Pt was advised by on-call nurse to go to E.R. Per call to MD office by Public Health RN 5/29/08, pt had gone to ER at 2033 5/28/08 where "local reaction" dx'd, pt given rx for Prednisone 20 mg, orally. Pt released and told to F/U w/her M.D. in 1-3 days.
Left arm pain began 10/05/2021 and radiated to the left scapula and shoulder joint.  For two days it was excruciating and difficult.  I took Tylenol and Aleve.  The pain subsided from a 10 to a 3 the last week of December, 2021.  I made an appointment with Orthopedics to investigate my on-going discomfort.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5ml (lot # L038917, expiration date 20-FEB-2018, route unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 304 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
The caller's wife mentioned that 2 of her friends got Shingles after the second shot; This is a spontaneous report from a non-contactable consumer via Pfizer-sponsored program . A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unknown route of administration on an unknown date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unknown date. On an unknown date, the reporter's wife stated that 2 of her friends got shingles after the second shot. Outcome of event was unknown.
15 year old patient given Moderna vaccine at walk up vaccine clinic. Not discovered until mother took child for second dose in November. Mother walked in to clinic in December to speak with someone and to have guidance on second dose.
Myalgia, Arthralgia, injection site pain, swelling. fatigue Narrative:
unusual side effects; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced unusual side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unusual side effects was not reported. This report was non-serious.
"Titer 6" After 2 Doses 1 Month Apart; Patient Received 3rd Dose of Heplisav-B; Initial Report Received on 06-Oct-2022  This is a spontaneous report, received from a nurse regarding a patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On an unknown date, dose 3 of HEPLISAV B (Lot # unknown, expiration date unknown, NDC # unknown), route and site not specified, was administered for hepatitis B immunisation.   The patient that had received 2 doses of HEPLISAV B a month apart did not convert and their titer was 6 so a 3rd dose was given.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
I'm currently 33 weeks pregnant, I have 1 living child born 2 years ago. This is my 2nd pregnancy. ETD is July 13, 2022.  So I woke up with a sore throat the morning of May 2nd I took a PCR covid test and it was positive. Next day, trouble catching my breathing, walking congestion and mucus. My daughter also tested positive but no symptoms. The next day, I got the antibodies infusion and that helped with the symptoms but I still had a cough for about 10 days.
In 2002 patient started to loose muscle and in May 2003, was diagnosed with ALS.  4/22/09 MR received from neuro 2/7/05 to 4/6/09 with DX:  Probable ALS, mostly lower motor neurons. Pt first noted sx of weight loss, leg cramps, dizziness and H/A and worsening dyspnea with exertion in 2002. Dx with probable ALS in 2003.  Over the years, progressively weaker with some absent and some decreased reflexes and strength. Dx changed to PMA (progressive muscular atrophy) by 11/2005. Still probable ALS.
Itching began at injection site within a couple of days and progressively spread, but not significant. As of today, noticeable and distinct red outline on arm, warm to touch. Still itchy. No treatments performed, as appears to be mild known side affect of injection.
Within 10 minutes after receiving MENACTRA, my daughter said I don't feel well, fainted, hit head on wall, began having seizure-like jerking, shaking and moaning and was unresponsive for a few minutes.
Pt given vaccine 6-12-07. Patient presented to office 8/17/07 for 2nd injection and c/o continued muscle soreness at injection site, especially when lifting arm up - c/o feeling of "pressure in muscle" when feeling on arm. No tenderness or palpation, no edema, nodules. Pt denies tingling, numbness, nerve s/s, 2nd injection withheld for now.
Patient received expired vaccine. Expired 3/26, received 3/28. No adverse events. Patient opted to not received revaccination.
Case number PHEH2014US021809 is an initial spontaneous report received from a nurse on 29 OCT 2014. This case refers to a 17 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on an unknown date. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) from 06-Mar-2021 to 07-Mar-2021 for Headache, at an unspecified dose and frequency. On 07-Mar-2021, HEADACHE (Headache) had resolved.            No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up information was received on 25 May 2021 : included no new information.
Pt recvd 3 doses of Engerix-b vax & did not respond; pt would not take any more doses;
Information has been received from a registered nurse and a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female patient who on 20-Jan-2009 was vaccinated with the first dose of GARDASIL (lot # 661764/0650X). The patient was pregnant. LMP was 04-JAN-2009, and estimated delivery date was 11-OCT-2009. The patient's mother had history of coagulation disorders, so blood work was taken on the patient with results pending to determine if the patient also had any unknown medical conditions that would affect the pregnancy. On 03-FEB-2009 urine pregnancy test was performed with positive result. The patient sought unspecified medical attention. Follow-up information was received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female patient with a history of 0 previous pregnancies and 0 of previous live births, who on 10-FEB-2008 (5 weeks from LMP) had a spontaneous abortion. The patient had not received any prenatal testing. The products of conception were not examined. The patient's mother had a history of coagulopathy which was not diagnosed. Upon internal review, spontaneous abortion was determined to be an other important medical event. Additional information has been requested.
Had four trips at a hospital and they keep working on his lungs and draining fluid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LUNG DISORDER (hospitalization), outcome "unknown", described as "Had four trips at a hospital and they keep working on his lungs and draining fluid". Therapeutic measures were taken as a result of lung disorder.  Clinical course: Reporter states, ah, yes, my son had a Pfizer rejection the 07Dec. And before the end of the month, he was at a hospital with life problems, and he had four trips at a hospital, and they keep working on his lungs and draining fluid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
starting about 24 hours after the first shot of the Moderna vaccine, i started feeling sick.  Fever, nausea, extreme fatigue, headache.  fever and nausea, with occasional headache has been ongoing for 22 days now.  Have missed a lot of work (i am a CEO of a public company).  the fever spiked about a week ago and doctor prescribed a general antibiotic.  fever went down for two days but then went back up.  he doctor sent me for more blood work and i will be receiving results soon.  i am due for the second shot in one week, but can't afford to get even sicker so won't be taking it.  i do need answers to my current condition.  i am sure the vaccine had adverse impact on my immune system.
Acute pain in middle of night to left jaw, upper and lower. Followed by parasthesias on left side of face. Visited Hospital ED on 8/16/2021. On prednisone 60mg x5d followed by 50, 40, 30, 20, 10mg taper and acyclovir 1g BID. NSAIDS did not control pain. Left facial weakness. Left facial
Back breaking pain for three days straight Extreme stress (persists but getting better) Soreness and inability to raise arm (persists) Fever Vomiting Rash/skin irritation Inability to breathe deeply (persists but getting better) Lower back and abdomen pain Tired/lethargy (persists)
Swelling of lymph nodes in left breast, armpit. Painful to touch, and unable put arm down at side for two days. This did not start until about 2 days after second vaccination. I had no adverse reactions from 1st vaccine. No other symptoms. Went away after 2-3 days of swelling. I took 2 Aleve twice a day for pain. Now it is fine.
pt recvd vax 6PM & @530PM while sleeping mom noted purplish mouth to around nose;woke pt up & started crying;purple color lasted 20mins-no resp problem, no sz;T102.6 @ hosp
24hr p/vax pt had an erythematous lesion to the site of inj;measured 2x5x3inches;no pain @ site;some edema;no fever;
I experienced hives on my hands and feet a week after receiving the vaccine (took antihistamines and the hives went away). I went to see my PCP  09/08/2021 in reference to my symptoms and was referred to get an allergy panel to rule out the environment and the results came back showing that I wasn't allergic to anything. I have basically been taking over-the-counter antihistamines. I'm very sensitive to hot weather.
Large swollen area around site of injection, developed painful lump underneath that slowly resolved, yet still has redness at site measuring 15 mm >30 days after injection.
Woke up next day with injection site and underarm pain that moved also to lymph node and breast swelling and pain.  Early that evening chills, fever, body aches, headache,  & dry cough that lasted most of the night.  The following day fatigue, runny nose, body aches, headache, swollen lymph node/breast area & arm tenderness continued.  The third day following the shot less fatigue, but still swollen area with pain and less headache.  Today, (day 4) minor headache, injection area, under arm and side of breast is still quite tender and swollen.  Research articles (U of MN, medRxiv services, etc.) indicate a 2nd shot may not be needed?????
At approximately 11:08 11 minutes after Pneumococcal vaccine injection, patient left nurse area to get a drink of water down following. Patient then felt heart racing BP was taken: 183/110, Pulse 96. Patient then taken to gurney area for observation and EKG. Discharged at 12:17p on 1/26/07.
Within 15 minutes of receiving vaccine, patient became short of breath, was audibly wheezing. Benadryl 50mg PO; Pulmo-Aid treatment with albuterol. Tolerated well. SOB improved. No audible wheezing except to auscultation right upper lobe only.
I got really low blood pressure, became shaky, and weak. General lack of energy. I went to the cardiologist and there was nothing found at this point. I am still experiencing off and on symptoms. The cardiologist completed a number of test but found nothing. The symptoms are still ongoing. No medication was prescribed. I went to the emergency room also and still nothing was found.
had a local reaction; gave it SC instead of IM; This case was reported by a other health professional via call center representative and described the occurrence of local reaction in a 16-year-old patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Meningococcal B Vaccine Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine (subcutaneous) and Meningococcal B Vaccine Pre-Filled Syringe Device. On an unknown date, unknown after receiving Meningococcal B vaccine and Meningococcal B Vaccine Pre-Filled Syringe Device, the patient experienced local reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the local reaction and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the local reaction to be related to Meningococcal B vaccine and Meningococcal B Vaccine Pre-Filled Syringe Device.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-Jul-2022 Reporter's comment: The heath care professional reported they had a patient who was given the Meningococcal B vaccine and had a local reaction, they discovered that the medical assistant accidentally given the vaccine subcutaneously instead of intramuscular route. No additional adverse event available as the reporter was unavailable at time of return call to the office. The reporter consented to follow-up. Additional supportive information: The patient received the Meningococcal B vaccine subcutaneously instead of intramuscular route, which led to intramuscular formulation administered by other route. The suspect was coded as per narrative information and the regarding outcome and outcome date query was raised.
Swelling, redness, warmth of arm over injection site that then spread to forearm just proximal to elbow.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 20Mar2021 at 11:00 as dose 1, single (Lot number: ER2613) at the age of 36 years, in right arm, on 14Apr2021 at 12:30 as dose 2, single (Lot number: EW0614) at the age of 36 years, in left arm and on 21Oct2021 at 15:00 as dose 3 (booster), single (Lot number: 1FF8841) at the age of 37 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "severe seasonal allergies" (unspecified if ongoing), notes: severe seasonal allergies; "herpies" (unspecified if ongoing), notes: herpies; "GERD" (unspecified if ongoing); "known allergies: Sulfa based meds" (unspecified if ongoing), notes: known allergies: Sulfa based meds. Concomitant medication(s) included: ROSUVASTATIN CALCIUM, start date: 01Apr2021, stop date: 27Jun2022; ESTRADIOL, start date: 01Sep2021; OMEPRAZOLE, start date: 01Mar2010; VALACYCLOVIR HCL, start date: 01Jul2016; SERTRALINE HCL, start date: 01Oct2016; LORATADINE, start date: 01Apr2013. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid to treat vaccination failure, covid-19, treatment start date: 28Jun2022, treatment stop date: 02Jul2022.  No follow-up attempts are possible. No further information is expected.
Patient c/o  of normal soreness/pain (post injection site pain of 2 on a scale of 1-10 with 0 being no pain) and pain in surrounding upper deltoid region, for three weeks. Later, the patient's spouse massaged her right upper arm at HS. When patient woke up in am, the pain in her arm  was escalated to an 8 on scale of 1-10. She c/o of difficulty moving arm away from her core, or elevating her arm. Due to this increased pain, she was unable to complete full ROM for 2 days. Afterwards, and continuing up to the present, she was able to complete full ROM, but with pain at 8 when trying to do so. Otherwise, pain level exists at a 2 for non full ROM activities throughout the day. Dr. advised client that bursitis sometimes happens after injections. Dr. suggested use of Motrin or Aleve for discomfort that may be caused by sleeping on her right side. Dr. suggested follow up with her MD for any increase in her pain. Dr. states if the pain is increased the MD may consider Physical Therapy or Ultrasound on the affected area.
Localized red rash 2.5cm that itches. Benadryl 50mg po q 4hr x 2 day given.
Patient received vaccination and a little leaked out.  Another dose was not administered knowing that the patient received at least 1/2 of the dose.
After the vaccination, before I got home, I became lightheaded and felt cold. About an hour and a half or 2 hours later I had a fever. For 2 straight days I had raging fever, vomiting, severe joint pain, nausea. Fever was the worst part, highest fevers were about 104.