chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very painful migraine after the 2nd shot; freezing; I'm still in pain; whole body hurts/body hurts more than I've ever experienced; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (very painful migraine after the 2nd shot), FEELING COLD (freezing), PAIN (I'm still in pain) and MYALGIA (whole body hurts/body hurts more than I've ever experienced) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic (Patient diabetic with injuries from an accident back in 2013).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (very painful migraine after the 2nd shot), FEELING COLD (freezing), PAIN (I'm still in pain) and MYALGIA (whole body hurts/body hurts more than I've ever experienced). At the time of the report, MIGRAINE (very painful migraine after the 2nd shot), FEELING COLD (freezing), PAIN (I'm still in pain) and MYALGIA (whole body hurts/body hurts more than I've ever experienced) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.   Reporter did not allow further contact
No adverse event; Broken VAQTA PFS/ Broken Syringe Barrel/ Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange; Caller reports one broken Hepatitis A vaccine, inactivated(VAQTA) pre-filled syringe (PFS). No adverse event (AE) or additional PQCs reported. Caller would send pictures and hold product for return. QUESTION SECTION: Medium Risk: Broken Syringe Barrel, High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for DPOC: Please provide a detailed description of the defect using the questions below: Is there a crack? NO o If yes, describe the size, shape & depth of the crack: NA o Provide the exact location of the crack on the syringe: NA; Is the syringe broken into 2 or more pieces? YES, If yes, describe in detail how it is broken: (e.g shattered, broken in half etc.) Tip is broken off o Provide the exact location of the breakage on the syringe? Tip - leur-lock is broken off o Does the syringe have a broken component? YES (e.g. broken syringe tip; loose or detached leur-lock, or broken finger flange) o If yes, describe in detail how it is broken: Leur-lock is broken off o Provide the exact location of the breakage on the syringe? Tip below Leur-lock o Is the tip of the syringe or Luer-lock adaptor loose or broken off of the syringe tip? YES (if yes describe): Broken Off o Was there difficulty trying to attach the syringe needle to the syringe? NA o If yes, describe NA o If yes, was it supplied by MERCK: NA o If not supplied by MERCK, what type & brand, needle size & gauge was used?' NA Under what situation was this defect noticed: (select one) o While the syringe was still in the tray? YES; If yes, is there product (liquid or dried residue) in the tray? YES o Is there any broken glass or other separated component in the tray? (if yes specify) Yes o After removing the syringe from the tray? NO; While trying to attach the needle to the syringe? NO o While giving the injection? NO; Immediately after g1v1ng the injection? NO; Was the syringe tip cap attached properly prior to use? NA o If no, describe issue: Was the syringe tray intact and undamaged on receipt? YES o If no, describe damage; If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. YES o If no, describe damage; Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO o If yes, describe; Was the product administered or exposed to patient' s bodily fluids (i.e. biohazardous)? NO; If complaint sample is not/cannot be returned, please provide reason: Caller will save for return; 18-NOV-2021, attached email and embedded pictures in a PDF file as well. See attachments. No new PQC. No additional information; 18-NOV-2021, based on the review of the PQC the priority for this record had been changed per Product Quality Complaint, Complaint Category and Risk Priority Table; 18-NOV-2021; Second person reviewed; 18-NOV-2021, at 15:30: Attachment added to Service Cloud; 18-NOV-2021 at 15:30: UPS Labels created Shipped on 18-NOV-2021; 19-NOV-2021: Second person reviewed performed for follow up activity.
Feb 12 left arm spelled up and was red and hot Feb 14 Low grade fever that woke me up at 2am Feb 14-15 fever persists off and on all day and sleep escapes me Feb 15 Diarrhea starts around 930 am and persists till 1230pm Feb 14-16 general aches and pains with fatigue
Client received first dose of Hepatitis B vaccine at approximately 3 pm on 5-7-07.  Reports she began feeling ill at 5pm that night.  She reported fatigue and a severe headache that did not respond to pain relievers.  Also reported having painful extremities and dull pressure under ribcage on right side.  Client did not seek medical care for symptoms.  She was unable to sleep that night due to headache.  Reports headache was improved by 4am.  On 5-9-07 client reported feeling better but still felt some fatigue/ malaise and still felt pressure under ribcage.
- Fever up to 101 x 72 degrees - Swelling of leg - Swelling & erythema 3cm in area of shot.
Complex congenital heart (hypoplastic (L)) repair with a modified normal/sano content. Vaccination 12/5 county on K/G expired en route to hospital 12/7. No post done at hospital. Vaccines were all #2 except Synagis #1.12/26/07-ER notes from facility for DOS 12/7/07-12/26/07-DX: cardiac arrest. Congenital heart anomaly. No autopsy performed.  12/27/07-COD hypoplastic left ventricle. CHF.
At age 16 months (February 2003):  Had Rotovirus.  Lost all previously acquired speech.  Lost ability to point, clap hands, and wave goodbye.  Stopped referencing parents for cues.  Lost all joint attention skills.  Lost interest in peers.  Stopped responding to name.  Lost ability to maintain even minimal eye contact.  In months following this regression:  Began playing repetitively with toys (or parts of toys) and engaging in perseverative play.  Began arm/hand flapping.  Would "zone out" and not seem to hear, see, or notice the world around him.  Began to actively avoid peers.  Began having tantrums over slight changes in routine.  Began having difficulty adapting to new places.  Began early intervention with school district (speech and occupational therapy) at age 20 months.  To date (6/30/2005), the only one of the lost skills that has been reacquired is clapping.  The only maladaptive behavior that has diminished is arm/hand flapping.  PLEASE NOTE:  I do not believe it was only the last batch of vaccinations (1/14/2003) received prior to the onset of symptoms in February 2003 that caused the heavy metal toxicity, but rather a build up of all the thimerosal-containing vaccinations he'd received since birth building up to a toxic "tipping" point that occurred in February 2003.  Your form does not allow for entry of this phenomena, so I've done the best I could given your form's parameters. Diagnosis from Medical Record rec'd on 07/25/2005 is autism.
Patient developed a headache the night of his COVID19 vaccine. The headache worsened during the day the next day and then improved in the evening. Headache then continued to improve over time.
Initial report received from a health care professional on 05 May 2008. A 23-year-old female patient with no known medical history received a subcutaneous injection of JE-Vax, lot number EJN232B, administered in the left arm. Two days later, on 01 May 2008, the patient complained of pins and needles in her left arm that extended to her left leg. She also complained of a headache. She was seen at an employee health center on 04 May 2008, but there were no findings. By the evening of 04 May 2008, all symptoms had resolved and the patient recovered. Follow-up information received on 30 June 2008 from the original reporter. Per the reporter, the patient had no illnesses at the time of the vaccination on 29 April 2008. It was confirmed that at the time of the vaccination the patient was taking concomitant medications of FLOVENT, ALBUTEROL, ZYRTEC, PATANOL, and VERAMYST for spring allergies. The patient had an MRI completed on 06 May 2008 that revealed an enlarged pituitary that will need further study. No demyelinating diagnosis has been made. Per the reporter, the patient did not continue the "series of vaccinations." Per this new information, this case was upgraded to serious.
little headache; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on an unspecified date in May2021 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) for covid-19 immunisation. Patient stated she received 2nd dose of vaccine on an unspecified date in May2021 (yesterday) and experienced little headache and was wondering if it would be safe to take something like ibuprofen or something. Patient did not clarify if she took something or not. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Child was given Varicella immunization. Child broke out in a rash all over his body and passed out. Epipen was used. 911 called. Transported to ER.
Patient received 0.5ml of the 6m-11yr Moderna Monovalent vaccine instead of 0.25ml.
Sick; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for immunisation. Medical history included immune system "compromised." The patient's concomitant medications were not reported. On an unspecified date, had a very bad reaction to that and was sick for almost 2 weeks." The outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Pt rec'd 10/17/08. Erythema 50 cent size, c/o itching, 2 minutes pustules at injection site.
On 4/25/08 - patient received GARDASIL #2. Within 50 minutes - onset of vomiting x 6 hours. Also developed fever 102, lethargy. Similar sxs - 3 days after GARDASIL #1 (2/18/08).
Patient was given a influenza injection on 11/1/13. Patient had already had an influenza injection for 2013 on 10/1/13.
@ 24 hrs post flu vax, pt began having seizures increasing over the following 16 hrs to almost status. She also had fever to 101. She already is a seizure pt on medication.
COVID vaccine breakthrough case J&J 3/22/21 1802068 and boosted 11/13/21 FG3527 and 10/10/22 GJ2377
Information has been received from a physician concerning the physician's daughter who was vaccinated with the third dose of GARDASIL. Subsequently the patient developed a lump where the injection site was given and it was hot. The patient had sought unknown medical attention and had an MRI done of her arm. At the time of report the patient's status was recovered. Additional information has been requested.
Eyes got swollen and swell shut day after; Bendadryl and Zyrtec has not helped just makes her sleepy; Rash that lasted for 15-30 min after vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EYE SWELLING (Eyes got swollen and swell shut day after), SOMNOLENCE (Bendadryl and Zyrtec has not helped just makes her sleepy) and RASH (Rash that lasted for 15-30 min after vaccine) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included MELATONIN and ALPRAZOLAM for an unknown indication.    On 05-Jan-2021 at 2:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced EYE SWELLING (Eyes got swollen and swell shut day after), SOMNOLENCE (Bendadryl and Zyrtec has not helped just makes her sleepy) and RASH (Rash that lasted for 15-30 min after vaccine). At the time of the report, EYE SWELLING (Eyes got swollen and swell shut day after) had not resolved, SOMNOLENCE (Bendadryl and Zyrtec has not helped just makes her sleepy) outcome was unknown and RASH (Rash that lasted for 15-30 min after vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Large local reaction. Area of redness, dark purple center, blistered center. Area now (10/31/13) is dark with white center (scar).
bad heart palpitations; numbness in the face; issues with hearing (coming and going)/hearing things that are not there; signs of psychosis; seeing illusions; seeing flashes of light in darkness; losing his appetite; tasting chemicals in my mouth; worsening my depression; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (bad heart palpitations), HYPOAESTHESIA (numbness in the face), HEARING DISABILITY (issues with hearing (coming and going)/hearing things that are not there), PSYCHOTIC DISORDER (signs of psychosis) and ILLUSION (seeing illusions) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced PALPITATIONS (bad heart palpitations), HYPOAESTHESIA (numbness in the face), HEARING DISABILITY (issues with hearing (coming and going)/hearing things that are not there), PSYCHOTIC DISORDER (signs of psychosis), ILLUSION (seeing illusions), PHOTOPSIA (seeing flashes of light in darkness), DECREASED APPETITE (losing his appetite), DYSGEUSIA (tasting chemicals in my mouth), DEPRESSION (worsening my depression) and FATIGUE (fatigue). At the time of the report, PALPITATIONS (bad heart palpitations), HYPOAESTHESIA (numbness in the face), HEARING DISABILITY (issues with hearing (coming and going)/hearing things that are not there), PSYCHOTIC DISORDER (signs of psychosis), ILLUSION (seeing illusions), PHOTOPSIA (seeing flashes of light in darkness), DECREASED APPETITE (losing his appetite), DYSGEUSIA (tasting chemicals in my mouth), DEPRESSION (worsening my depression) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No relevant concomitant medications were reported. No treatment information was provided.
12 days after vaccine: intense hives on both upper arms, chest, both sides of face.  lasted 2 days .   Hives went away after day 14  but now have red itchy rash over body.  Hives and burning itch persist day 23 after vaccine.  My dr. referred me to dermatologist  who examined me on 2/23/21, viewed pictures of my hives, and examined my back rash.  She advised me to start double dosing on Zyrtec and to proceed with Moderna booster but to report to this site.   Zyrtec does not seem to relieve my ongoing itchy rash symptoms
An expired Covid-19 pfizer vaccine was administered to the patient on 4/28/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient on 5-9. She does not plan to get revaccinated.
Delayed cutaneous hypersensitivity:  Two days after vaccination, developed large (5 inch by 2.5 inch) red patch on left upper arm which was slightly swollen, mildly itchy, and warm to the touch.
8 days after injection, arm became swollen around the injection site; swelling subsided after 4-5 days, upper arm itched for more than a week, severs at first and gradually subsided
body aches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and PYREXIA (low grade fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, SERTRALINE and BUPROPION for Antidepressant therapy, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT) for Asthma.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced MYALGIA (body aches) and PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (body aches) and PYREXIA (low grade fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient went today 04-May-2021, to pharmacy, in order to receive the 2nd dose of Shingles vaccine and accidentally patient received the 3rd dose of Moderna vaccine in the left arm.  Action taken with mRNA-1273 in response to the event was not applicable    This case was linked to MODERNATX, INC.-MOD-2021-103961 (E2B Linked Report). This case was linked to MOD-2021-104078 (Patient Link).; Sender's Comments:  MODERNATX, INC.-MOD-2021-103961:dose 1
Information has been received from a physician's assistant concerning a 31 year old female who on 02/04/2005 was vaccinated with a dose of varicella virus vaccine live.  It was reported that no other vaccinations were administered at that time.  On 02/09/2005 the patient developed itchy macular papular bumps.  Unspecified medical attention was sought.   No treatment was prescribed.  The patient's outcome was reported as not recovered.  There was no product quality complaint involved.  Additional information has been requested.
Swelling and pain in armpit of arm where shot was administered. Armpit swelled to size of baseball. Pain prevented putting arm at side for over 48 hours. Ibuprofen and Tylenol did not reduce pain or swelling. This was the most severe symptom that lead to contacting a doctor. Swelling reduced on its own  about 6 days after 3rd dose injection. Other symptoms that were the same as the second dose included fever, body and muscle aches, joint pain, nausea, diarrhea, arm soreness, redness at injection site.
Started child on Rotateq oral vaccine #1 dose 8-15-07. Discovered 8-16-07 child was 16 weeks of age when dose started 4 weeks older than recommended age to start Rota vaccine series.
Severely sick after second dose; This is a spontaneous report from a non-contactable consumer. An adult female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: not reported), via an unspecified route of administration in Jan2021 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on an unspecified date. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient was severely sick after second dose "never been so sick" in Jan2021. It was unknown if there was a treatment received for the adverse event. It was unknown if the patient has been tested for COVID-19 since the vaccination. The outcome of event was unknown. This case is non-serious.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
INCORRECT DOB WRITTEN ON CONSENT FORM RESULTING IN GIVING OF VACCINE TO UNDERAGE INDIVIDUAL
PATIENT CAME TO THE PHARMACY SAYING HE HAD A LUMP UNDER HIS LEFT PECTORIAL MUSCLE.  HE STATED IT HAPPENED ABOUT TWO WEEKS AFTER AREXVY.  PATIENT LEFT TO GO HAVE IT CHECKED OUT BY HIS PRESCRIBER.
BLACK TARRY STOOLS; FLUID AROUND THE HEART; FEET SWELLING; BLOODY DIARRHEA; This spontaneous report received from a consumer concerned a 90 year old male. The patient's height, and weight were not reported. The patient's past medical history included cardiac stent placement, and concurrent conditions included Alzheimer's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: unknown) dose was not reported, one total administered in left arm on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the patient was started to have swelling in feet. Patient went to the hospital for heart trouble because had fluid around heart. On 05-MAY-2021, Patient had bloody diarrhea. On an unspecified date, patient also complained of stomach pain and black tarry stools. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feet swelling, fluid around the heart, bloody diarrhea, and black tarry stools. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210643383 and 20210642487.; Sender's Comments: V0:20210644172-covid-19 vaccine ad26.cov2.s-Black tarry stools, fluid around the heart, bloody diarrhea.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Severe emotional outbursts and disconnected. He cried and said he hurt and begged us to take his pain away. His issues have at times been very difficult. We have worked with him at home by practicing behavior control and patience. In 2015 doctor suggested possible Asperger.
Patient was nauseas  and lightheaded. She was instructed to lay down  in which she felt better.