chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient up to date on vaccines, booster on 12/09/21 who admitted to hospital for COVID complications and subsequently died.  Provider discharge note below:  "81 YO M with a PMH of CLL, PAF and COVID was just recently discharged on 2/4/22 for respiratory failure 2/2 COVID. He was given remdesivir and finished on a course of 10 days of steroids which he last took on 2/9. The patient was feeling okay while home but yesterday he started getting more fatigued and this morning he had a fever of 101. His wife was getting worried as he was also having a more productive cough.  ER work up was significant for hypoxia--initially was bumped to 5 L o2 and now on venti-mask. Because of his hx of pericardial effusion, an ED bedside US showed only trace fluid around heart. CBC showed leukocytosis of 17, CXR showed patchy alevolar inflitrates. There was a concern for bacterial infection--was given Vanc/merrem in setting of cephalosporin allergy. The patient also had a BNP which was in the 700s, strep/legionella testing was negative as well. He will be admitted for further w/u.   Hospital Course: The patient was admitted for acute Respiratory failure from COVID pneumonia and was treated for superimposed bacterial pneumonia, Sepsis from viral and bacterial pneumonia. He completed course of Unasyn, Doxy. hehas underlying CLL, and with consultation with Doctor he received IVIG. He has a HX AFib, HTN. ECHO shows normal EF with mod pericardial effusion with no tamponade.  He continued to decline during the course of illness and during the last several day, continued with failure to thrive and indicated on several occasions he did not want to survive. He was maintained on Bipap which he had a hard time wearing.  Earlier this morning her briefly pulled detached the bipap tubing and Rapid response was called for respiratory distress and subsequently with placing him back on Bipap he had labored respirations with ABG showing worsened acidosis, with hypoxia and hypercarbia.  I discussed with family on overall prognosis and consideration for Comfort care was discussed. After discussion with all family members, Bipap was removed for Comfort care, and he subsequently passed peacefully. "
Myalgia, Arthralgia, Fever & NauseaVomiting Narrative: flu-like symptoms
Increased pain at injection site, inability to move arm freely and bruising extending 6 inches below injection site.
Patient experienced some right arm soreness in the days following the injection. Then a few days later, the patient noticed redness, warmth, and skin tenderness at the site of injection. When patient presented to the pharmacy on 8/7/18, injection site was still very red, warm and had raised bumps at the center.
no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 15-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
On 6/20/16 noted soreness and numbness to left deltoid muscle, continues through today. Patient came into clinic to have this nurse see her left deltoid muscle after her mother called this morning. Left deltoid muscle, area of hardness noted, and sore to touch, but patient said, not as bad as it has been, no inflammation noted at site. No treatment given.
CHEST PAIN, SORE THROAT, FATIGUE, SEVERE CHEST PAIN
dysequilibrium, poor balance, nausea x 5 days starting 6 days after visit. possible vertigol
pt recv vax; exp arthritis & arthralgia;f/u info stated sx not related to vax;
Right elbow swelled with what looks like a fluid- filled sack approximately 4mm x 3mm in diameter.; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 24Feb2021 at 15:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 12Mar2021, the patient experienced right elbow swelled with what looked like a fluid- filled sack approximately 4mm(millimeter) x 3mm in diameter. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right elbow swelled with what looks like a fluid- filled sack approximately 4mm x 3mm in diameter was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
1/12/10 Hives, swelling of fingers, hands, feet, face arms, low to high fever, paleness, muscle ache.
extreme pain/mild soreness; muscle spasm; nerve pain in my right arm into my neck; This is a spontaneous report from a contactable pharmacist.   A adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient took historical vaccine (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 product COVID 19, lot unknown False, for covid 19 immunisation.  On 05Feb2021 the day after receiving the second dose of my Pfizer COVID vaccine, patient began having extreme pain and muscle spasm/nerve pain in my right arm (where patient got my injection) into her neck. The pain was only resolved after IM Toradol and PO cyclobenzaprine. Patient still have some mild soreness in these areas. Pain was 10 out of 10 - worst pain ever experienced. There is no seriousness criteria such as Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. Prior to vaccination, was the patient diagnosed with COVID-19 was Unknown Since the vaccination, has the patient been tested for COVID-19 also unknown. Therapeutic measures were taken as a result of extreme pain/mild soreness (pain), muscle spasm (muscle spasms), nerve pain in my right arm into my neck (neuralgia). Outcome of the events was unknown. Information on the lot/batch number has been requested Follow-up attempts completed. No further information expected
Patient fainted and fell to the ground from a sitting position. Pharmacist instructed family member to call 911 as patient's eyes were open at time of lost consciousness. After about 10 seconds patient regained full consciousness and was able to sit up and drink water. EMS arrived to assess patient's vital signs and reported no issues except patient had somewhat low blood sugar. EMS instructed patient to stay hydrated, rest, and eat.
Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 ml dos of HPV vaccine. Subsequently, the patient fainted. Unspecified medical attention was sought. A short time after vaccination, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Petechial rash on day 5 + 6 after immunization was told had viral exanthem, seen on 5-19-07 seen in ER , Plat ct 15K, seen again on 5-21-07 with Pl ct = 2K, admitted 5-21 - 5-24-07, for ITP given IVIG now plate ct - 58K; not sure if MMR or viral etiology. 7/5/07-records received for DOS 05/21/2007-DC Summary not available. HX of hives on 5/17/07-also 'gunky eyes'. On 5/19/07-developed fever 101.8 and red dots on face and in his mouth, Platelets 15,000. Also diagnosed with acute otitis media and a rash, and ITP. Continued with fevers over next 2 days, some bruising 2 days prior to admission. Platelets 2000. HX of runny nose 3 days prior to admission and cough on day of admission. Temp 35.4. PE: Extensive petechiae and bruising of various sizes all over his body.
expired dose of Pneumovax 23 was administered to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.   On 08-FEB-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S005856 has been verified to be a valid lot number, expiration date was not reported, but upon internal validation, it was established as 03-DEC-2020, 0.5 ml administered intramuscularly for prophylaxis. The reporter confirmed that the vaccine has had no temperature excursions and has been stored according to the recommended temperature range. No other information provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.devicelotnumber: S005856; expirationdate: 03-DEC-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient was 17 and 6 month at the time of administration and Moderna is indicated for 18 years and older. Patient didn't experience any adverse events.
itchy; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and RASH (rash) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy) and RASH (rash). At the time of the report, PRURITUS (itchy) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown  Treatment information was unknown
Information has been received from a registered nurse concerning a 14 year old female patient who 14-DEC-2007 and on 07-MAR-2008 was vaccinated with the first and second dose of GARDASIL vaccine (yeast) respectively. There was no concomitant medication. The registered nurse reported that within 24 hours of vaccination with the first dose of GARDASIL vaccine (yeast) on 14-DEC-2007, the patient developed a fever of 101 degrees F, nausea and flu like symptoms. It was unclear how long the fever, nausea and flu like symptoms lasted. The patient recovered. On 07-MAR-2008, the same night after the second vaccination with GARDASIL vaccine (yeast), the patient developed a fever of 102 degrees F, nausea and flu like symptoms that lasted for "several days". On an unspecified date, the patient recovered. It was not specified if the patient sought for medical attention. There was no product quality complaint. Additional information has been requested.
Burning pain in under arm,  sensation to chest area, joint aches, skin rashes, head aches, lower back pain
This spontaneous report was received from a registered nurse, concerning a 67 year old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On 16-SEP-2017 (reported as "10 days ago"), the patient was vaccinated with VARIVAX and sterile diluent (manufacturer unknown), for prophylaxis; instead of ZOSTAVAX (lot #, expiration date, strength, dose, route of administration or anatomical location were not reported for neither of them). No adverse effects were reported. No product quality complaint (PQC) was involved.
This case was reported by a nurse via call center representative and described the occurrence of hives in a 5-year-old male patient who received PEDIARIX (batch number FY7FK, expiry date 27th May 2016). Concurrent medical conditions included conjunctivitis. Concomitant products included POLYTRIM. On 19th April 2016, the patient received PEDIARIX .5 ml. On 20th April 2016, 1 days after receiving PEDIARIX, the patient experienced hives. The patient was treated with BENADRYL. On an unknown date, the outcome of the hives was recovering/resolving. The reporter considered the hives to be possibly related to PEDIARIX. Additional details provided were as follows: The patient had conjunctivitis at the same time and was given POLYTRIM drops on the vaccination day. The patient developed hives on his abdomen and legs. The physician advised the patient to take BENADRYL and the hives seemed to lessen but were still visible. The reporter stated no respiratory involvement at this time.
The cases were received on 21 March 2014. Initial misuse report received from a healthcare professional on 21 February 2014. A '61-year-old' patient (no information was provided regarding the patient) had received dose of FLUZONE HD on an unspecified date, i.e. inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none.
T to 104 F,high pitched cry for 48 hrs.Vomiting for 2 days.Child is improved as of 15Jun90.T down.No problems /w prior DTP. No allergy hx, family hx of allergies,no sibling, 3rd injection.
HYPOXIA 12/12/2022 CANCER METASTATIC TO INTRATHORACIC LN
Patient is under the recommended age of 18 to receive the Jansen vaccine. The vaccine was administered prior to our understanding that the Jansen vaccine was only labeled for those 18 and older.  The patient had so significant adverse reactions to the vaccine.
Burning, itching rash all over body that began the night of the  vaccine; Burning, itching rash all over body that began the night of the  vaccine; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 45-year-old, via an unspecified route of administration, administered in left arm on 21Feb2021 08:30 (Lot Number: EL9269) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced burning, itching rash all over body that began the night of the vaccine on 21Feb2021 20:00 and progressively spread all over 3 days later. The patient did not receive any treatment for the events. The outcome of the events was recovered on 28Feb2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from a RN concerning a male who in August 1998, at 15 months old, was vaccinated with a dose of Varivax. In August 1998, one week after vaccination, at 15 months old, the child experienced a seizure. No seizure was noted prior to vaccination. Approximately one month after the seizure, 5 weeks post vaccination, in September 1998, at 16 months old, the child was found dead in his crib. The autopsy stated the cause was SIDS. Unspecified medical attention was sought. There was no product quality complaint. The reporter considered the events to be life-threatening. No additional information is expected. As per autopsy report rec'd 07/18/2005 -- remove SIDS and add Reaction unevaluable.
No adverse effect reported; inadvertently administered a dose of VAQTA on 7/5/2019,  that had been improperly stored; Information has been received from a vaccine coordinator (also reported as administrator), referring to a patient of unknown age or gender. Information of concurrent condition, medical history and concomitant therapy was not provided.   On 05-JUL-2019, the patient inadvertently administered a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) (strength and route were unknown) (the involved vaccine included: lot # was reported as R023606 and expiration date 06-MAY-2021; lot # S002460 and expiration date 15-MAY-2020; lot # R034340 and expiration date 23-NOV-2019) for prophylaxis (product storage error). No adverse effect reported.  It was reported that the vaccine underwent a temperature excursion of 49.3 Fahrenheit degrees for 4 hours 30 minutes. There was no previous excursion. The call was because of a data logger.
Vaccines given in clinic  then 4 hours later at home fussy and rash on left leg. The urticarial rash from upper thigh to nearly down to knee on the lateral side . The rash spread to shoulder bilaterally and buttocks  no identified food triggers for rash  consider bandaide reaction
Extra Dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 62-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 53BF4, expiry date unknown) for prophylaxis.   On 26th August 2019, the patient received the 2nd dose of Boostrix. On 26th August 2019, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional case details were provided as follows: The patient received 2nd dose of boostrix, which led to extra dose administered. The reporter did not consent to follow up.
Client's mother called in and left a voicemail stating the client had been hospitalized for intussusception and subsequently undergone surgery following the vaccination.  Multiple voicemail were left attempting to contact mom to inquire re: patient and gain further details but client's mother has not called back.
Post pt's 4th dose of vax, the pt developed localized lymphadenopathy in the left supraclavicular area the next day. In the 2-3 days that followed, the lymph node redness abated. Lymph node size decreased, but is still palpable. Additional info was received on 10/27/2000. The female pt received RabAvert on 08/31/2000, 09/03/2000, 09/07/2000, 09/17/2000, and 09/28/2000. On 09/15/2000, the day after she received her fourth RabAvert vaccine in her left deltoid muscle, she experienced supraclavicular adenopathy. A large 3 x 3cm tender, raised mass was seen in the left supraclavicular region. She recovered on 09/21/2000.
no adverse effect just vaccination history was showing 1 shot and second dose is due, pharmacist helped pt with second dose she forgot she got it at cvs. After going home they found out that the shot she got with us was her second.
Mild soreness in the injection site and general achiness started within the first couple hours of taking the vaccine Headache, weakness and flu like achs started in the evening on the same day with mild elevation in temperature (99 F underarms) Symptoms peaked the next day with a temp of 101 F underarm .. Sever headache and flu like muscle and joint pains and more pain at the injection site but when pressure is applied ( like trying to sleep on that side) plus tender swollen lymph nodes on the neck only on the left side ( same side where I got the injection) On the third day achs and pains were very mild and fever subsided .. Sever headache, pain at injection site with applied pressure and swollen neck lymph nodes lasted about a week then completely resolved
9/25/08 "Hours after reciving vaccine, I began to experience pain under my left armpit (lymph nodes enlarched) and some swelling on the same side/arm I received the vaccine".  9/30/08 "I still have the swelling and pain is increasing".  No other adverse reaction noticed, site of injection without redness or swelling at the time of filling out report.
very sore arm; experienced fever; headache; chills; This is a spontaneous report received from a contactable consumer (patient). A female patient of unspecified age received BNT162B2, dose 2, via intramuscular on 06Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history included type 2 diabetes. Concomitant medications included trilobite, metformin, and insulin glargine (LANTUS) taken for type 2 diabetes. The patient received her second covid vaccine on 06Apr2021. On 07Apr2021 experienced fever, headache, chills, very sore arm. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.