chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Moderna Covid-19 vaccine after the manufacturers expiration date.; Patient received Moderna Covid-19 vaccine after the manufacturers expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the manufacturers expiration date.) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the manufacturers expiration date.) in a 37-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 026D21A and 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Jan-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the manufacturers expiration date.) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the manufacturers expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the manufacturers expiration date.) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the manufacturers expiration date.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-577165, MOD-2022-577166, MOD-2022-577168 (Patient Link).
Bad Flu-like symptoms and break thru Covid, 750 ml sodium chloride, ongoing issue.
Initial report received on 11 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in the two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received three doses of PENTACEL; lot number C3545AA on 09 December 2009, lot number C3541AA on 16 February 2010, and lot number C3579AA on 08 April 2010, and one dose of DAPTACEL; lot number C3577AA received on 05 July 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 21 August 2012, approximately 14 months after the last dose, and a paroxysmal cough with a whoop on 25 August 2012. The subject also developed posttussive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 26 August 2012. Chest x-ray findings were positive for pneumonia. Corrective treatments consisted of azithromycin starting on 27 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 13 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
body aches; arm pain; discoloration in bowel movements; bowel changes; fatigue; headache; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced general body pain, pain in arm, stool discolored, bowel discomfort, fatigue and headache. On an unknown date, the outcome of the general body pain, pain in arm, stool discolored, bowel discomfort, fatigue and headache were recovered/resolved.   It was unknown if the reporter considered the general body pain, pain in arm, stool discolored, bowel discomfort, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not want to provide their full date of birth and gave permission to follow up with their HCP. The patient received Shingrix and experienced body aches, arm pain, discoloration in bowel movements, bowel changes, fatigue and was not sure if she had a headache.  Adverse events had resolved and only lasted 4 to 5 days. The reporter consented to follow up. Not all information was available.
Administered flu shot at 2:30pm. Patient returned to pharmacy counter at 2:40pm complaining of not feeling well. I instructed her to take a seat in the waiting area and she put her feet up on a chair. She then complained of feeling like it was hard to swallow. I activated the emergency protocol and instructed my cashier to call 911. I obtained the blood pressure monitor and EPIPENS. I took the patient's blood pressure at 2:49pm. It was 130/80. Patient complained it was still hard to swallow but was not having difficulty breathing. Emergency responders arrived at 2:51pm and took over patient care. Patient was then taken by emergency responders to the emergency room.
My shot was on Sunday, at midnight that night the headache  began. Monday, called into work. Monday I had a horrible headache, arm swelled to about a golf ball size at shot site. My whole left shoulder to almost mid back was in pain all day. Tylenol and ibuprofen did not touch back/shoulder pain or headache . I was very tired. Tuesday same thing horrible headache and arm soreness, yet not as bad for back pain. Didn?t go to work. Wednesday tried to go to work but had diarrhea horribly and a headache, ended up leaving only a few hours of being there. Thursday , called in sick again with a horrible headache. Called family physician to be checked. 3 and 1/2 days off work. Dr. Decided to treat it as a migraine, prescribed me medicine and headache has been gone since. It is late Thursday night, 25th. Also my blood pressure was high when I went in, usually 120/80 and today it was 144 or 140 over 80
Presents with lower extremity swelling with associated shortness of breath and c diff symptoms. Kidney function poor need dialysis. Diuretics needed. Pt discharged.
15:40: Patient was noted to be uncomfortable by observer and I was called over 15:41: I had patient walk to Med Eval 3 room 1, she states she has facial itchiness, stomach pain, and nausea (Patient only speaks Spanish) 15: 42: An interpreter (virtual) was brought to room via tablet by EMS. 2 EMTs were present through out patient care.  15:45: Vitals were taken by EMS (P: 82, O2 Sat: 98 on RA, BP: 114/90, Resp: 18) initially (please see EMS documentation for further vital signs 15: 45: Patient confirm no known drug allergies, Benedryl 50mg (12.5mg/5ml ) given PO x 1 dose here.  15: 45: Lungs auscultated by EMS, clear bilaterally per EMTs exam, patient is not in acute distress and can take deep breaths easily 15:50: Patient continues to rub and scratch face, continues to be flushed. She states her lips feel a little swollen and itchy when asked. She is feeling a little dizzy but continues to sit up. 15:03: Patient agrees to transport to ER for further evaluation, treatment and observation. 16:04: EMS Responds  16:05: Vitals Reassessed by EMS (VS: 16:08 P 70, BP 113/80, Resp: 18), her lungs were auscultated again and were found to be clear. She was able to speak in complete sentences without difficulty while on stretcher and being rolled out of Med Eval on way to ambulance. Her cousin will go with her and serve as an interpreter.   Of note: During my history patient states she has not taken any of her normal medications today, since she forgot. She has a history of allergic reactions that were treated with oxygen and inhalers. She also notes that her anxiety disorder also causes itching, but only ever on her arms and never on the face.
Pt stated noticed redness / splotching and felt expanded next AM. No itchy but yes pain. Today better but saw MD and MD said just use hydrocortisone cream. Is better now.
Patient developed acute headache (atypical of migraine headaches in past) with associated nausea and vomiting and low-grade fever.  Symptoms began one day after receiving second dose of vaccine.  Patient attempted to manage her symptoms with Imitrex and Zofran - no relief.  Treated in our facility with IM Toradol and Zofran ODT and sent home with prescriptions for Fioricet, Reglan, and Compazine suppositories.
Vomiting 12 hours post vaccine.  24 hours post vaccine temps 104+ to  106.8 temp orally  30 hours post vaccine.  Red swollen eyes 24 hours post vaccine.   Ringing in ears and temporary loss of hearing comes and goes.
PT FELT OUT OF BREATH AFTER 10 MINUTES OF ADMINISTERING VACCINE, WE CALLED 911, FACE TURNED RED SHE STARTED GETTING WORSE AND SWEATING GASPING FOR AIR, I GRABBED THE EPI PEN FROM PHARMACY AND WHEN I CAME BACK SHE FAINTED AND I ADMNISISTERED IMMEDIATELY. SHE WAS OUT FOR 30 SECONDS LIFTED HER HAD AND WAS ALERT. THE AMBULANCE CAME TO CHECK HER AND SHE DECIDED TO GO TO HOSPITAL TO MAKE SURE EVERYTHING WAS OK.
pt recv vax & starting in late afternoon, pt started crying uncontrollably for a couple of hours;pt never did this w/any other shots;
Covid : Deep racking cough - hard to get air, congestion, runny nose, clicking in ears & sound got louder and fainter (1 day), loss of taste and smell (3 days), chills. Telemed call and prescription for Paxlovid. Got sick 12/15 but tested negative for two days. Tested positive on 12/17 and had telemed call. Started Paxlovid. Finished Paxlovid on 12/21.  Sick through 12/29.
Small red spots on day 1, progressing on day 2 to 200+ target lesions on arms, legs, hands, soles.  Severe itching over several days. Oral and topical antihistamines given. Considering prednisone.
pneumonia; Initial information received on 25-Oct-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional.  This case involves a patient (unknown demographics) who experienced pneumonia after receiving INFLUENZA VACCINE.  The patient's medical treatment, vaccination, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event. This event was assessed as medically significant.   It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  Information on the batch number was requested.; Sender's Comments: This case involves a patient (unknown demographics) who had pneumonia, after receiving INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of the events, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of a vaccine cannot be assessed.
Redness and inflammation at the injection site.  Itching patient is going to apply ice and take antihistamine.
Dizziness, blurred vision, orthostatic hypotension, weakness, fatigue, dehydration, tiredness, nausea
Within 24 hours of vaccine, patient felt nausea, dizziness.  Severe fatigue and body aches, 102 degree F fever and headache x 3 days.  Shortness of breath x 1 day.  Redness, inflammation, heat at area of vaccination and "red line" x 5 days.  Instructed patient to apply cold compress and take NSAID. Patient believes she was positive for COVID last fall.
Totally destroyed me the day after with aches and pains; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received all vaccines and had taken and did and would continue to take them all.  The patient reported it destroyed the day after with aches and pains. The reporter recommendation was take it on and if work through the week but please take it.
Case number PHEH2016US022039 is an initial spontaneous report received from physician on 25 Aug 2016. This report refers to 63 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1517501, expiry date: Jun 2016) at a dose of 0.5 ml intramuscularly 25 Aug 2016, which was expired in Jun 2016. The Six patient were administered FLUVIRIN that was expired in Jun 2016. No adverse event was reported following this medication error.
This spontaneous report was received from a medical assistant and refers to a 44 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 17-SEP-2018, the 44 year old patient inadvertently received a dose of PROQUAD lot # R001541 with expiration date of 15-JUL-2019, for prophylaxis (route and anatomical location were not reported), and a dose of sterile diluent (MERCK) lot # N030845  with expiration date of 12-JUN-2020 (route and indication were not reported). No adverse effects were reported.
Patient had no energy in the first 24 hours and then began a steady decline that started with vomiting after 48 hours, then an inability to swallow and ultimately the patients death on 2/5/21.
Client stood up after receiving vaccines talking with family and then fell to floor.  Mother states she saw his eyes roll but he never lost consciousness.  He was placed on a mat with legs elevated and a cold towel.  He was able to speak clearly and his eyes were equal and clear.  After resting for about 20-30 minutes his brother helped him to the restroom and then to the car.  Client was alert and coherent.
This spontaneous report as received from a nurse refers to a patients of unknown age and gender. On an unknown date GARDASIL (dose, route and site of administration were not reported) vaccines have been administered to multiple patients post supported excursions. No adverse effects reported by any patients. This is one of several reports from the same source. Additional information has been requested.
Passing bright red blood mixed with clear mucus-like discharge  from my uterus/vagina even though my period is due 2 weeks away. Spotting for the past few days -- and still spotting. Some lower abdomen cramping.
Since the vaccine is a rna duplicate that makes the body create the protein that the antigen ?rapid tests? test for - I am now testing false positives on antigen rapid tests at work and continue to need to go home until my pcr test comes back negative hours later, which is always does.  Please publicize this problem so I don?t loose more work because of these inaccurate tests that are getting tripped by my vaccine.
R arm, red, swollen, painful 24 hours later - cellulitis.  Injection Rocephin, Augmentin
abdominal cramping; diarrhea; sore arm day of injection (dose 2); This is a spontaneous report from a non-contactable consumer (patient). A 72-years-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration at arm left on 16Feb2021 at single dose for COVID-19 immunisation. Medical history included cirrhosis unknown origin, autoimmune disease/unknown origin and no known allergies. Concomitant medication included sertraline hydrochloride (ZOLOFT), omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included 1st of BNT162B2 on 26Jan2021. The patient experienced sore arm day of injection (dose 2) on 16Feb2021, abdominal cramping/diarrhea post dose day 2 (17Feb2021) vax 2. No treatment was received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.  Information on the lot/batch number has been requested.
Large red bumpy rash on the arm where injection was administered(left arm).   Entire upper arm had a large hard lump that was incredibly hot and tender to the touch.    Appeared approximately 10 days after the vaccine was administered.  The rash and lump lasted approximately 3 days
Information has been received regarding a case in litigation concerning a minor child with heavy metal exposure who, during the period from 4/12/96 through 4/24/97, was vaccinated with MMR II and other unspecified IM vaccinations. It was alleged that the vaccinations subjected the pt to very high doses of mercury and other heavy metals contained in the preservative thimerosal. The case was as follows: It was alleged that the pt became neurologically devastated by the accumulation of mercury in his body, having been exposed via multi-source exposure, which included, but was not limited to power plant emissions, and/or intramuscular vaccinations, either alone and/or in conjunction with the MMR II and suddenly regressed developmentally. It was also reported that the use of the live MMR II had injured the pt by causing mercury toxicity and associated neurological injuries with specific symptoms and sequelae. It was alleged that the highly toxic emissions of certain power production facilities in the environmental zone in which the pt resides and regularly engages in his life activities has contributed to the pt's total dose of poisonous mercury. The pt's heightened vulnerability to the heavy metals contributed to his condition by the power production facilities' fossil-fuel burning process. It was reported that the pt's impaired condition was compounded by these exposures and his injury made worse by them. It was reported that after the pt's parents became aware that the pt's development had halted and/or reversed by some then-unknown cause, medical professionals were consulted, who diagnosed the pt as suffering from autism, as well as complex neurodevelopmental disorder characterized by autoimmune encephalopathy, secretory IgA deficiency, chronic Candidiasis and Klebsiella enteritis, chronic sinusitis and post-infectious autoimmune encephalopathy whose symptoms were materially indistinguishable to those of mercury poisoning. The pt has sustained and will sustain mental, intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders, physical impairment and disfigurement. No further info is available. Upon internal review it has been determined that the pt's complex neurodevelopmental disorder, physical impairment and disfigurement, post-infectious autoimmune encephalopathy and autoimmune encephalopathy, autism and mercury toxicity were considered other important medical events (OMIC).
Severe neck pain; Stiff neck on right side.; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26May2021 (at the age of 42-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The information on known allergies to medications, food or other products was not applicable. The clinical course was reported as follows: on 26May2021, the patient experienced severe neck pain and stiff neck on right side. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events of severe neck pain and stiff neck on right side was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to a 12 month old patient. The concurrent condition, medical history and concomitant medication was not reported. On 21-JUL-2015 the patient was inadvertently vaccinated with M-M-R II, 0.5 ml, subcutaneously and PROQUAD (Merck) (dose, route and lot details unavailable). No adverse effects were reported. Additional information has been requested.
Headache, stomach pain, vomiting, fever, chills, weakness, skin hypersensitive to touch.
I developed what felt like a low grade viral illness - run down and achy. I noticed I had a couple of blisters on my right arm. I had some itchy spots on neck and shoulder part. I couldn't see them right away. The blisters looked classic with shingles and I sent photos to my doctor. My doctor said it could be shingles. I started on Valtrex right away. I think the next day (or within 48 hour) I had confusion, headache and a little discoordination. I was worried it was turning into encephalopathy   - with the viral infection. I think they did imaging when I went to ED - March 2nd. I was fairly out of of it.  Gave me some Anti-nausea medicine and gave me some fluid and I think I got some Toradol. I didn't get any narcotics. . They continued with my anti-virals. Within a day and  a half things started coming around I did develop neuropathy. I did have some healing spots on my neck and shoulder - they didn't know if it was related to shingles. ED doctor wasn't convinced it was shingles but my primary care doctor thought it was. Supportive care after the ED visit. I still have some scars but all the neurological stuff cleared up within a couple of days after the ED visit - by the 4th or 5th of March.
Patient had no known side effects; Vaccine Coordinator reported a temperature excursion for VAQTA which was supported. Caller reported that 1 dose of VAQTA was administered to a patient.; This spontaneous report was received from a vaccine coordinator, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 04-JAN-2022, the patient was vaccinated with a 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # U024505, expiration date: 15-OCT-2022; strength, route and site of administration were not provided) for prophylaxis (product storage error). Temperature excursion for hepatitis a vaccine, inactivated (VAQTA) was supported. The patient had no known side effects (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2201USA006297: