chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Drug allergy (Lisinopril allergy).    On 19-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  This vaccine was removed from freezer on 31-Aug-2021 and was stored in a monitored refrigerator. By manufacturer guidelines, refrigerator thawed vaccine had a storage life of 30 days (29-Sep-2021) and the vaccine was administered after 29-Sep-2021.   This case was linked to MOD-2021-374588 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Added Patient details and updated patient demographics. Patient's current and medical history was updated. Updated the event description in the I narrative.
12 year old received full dose of moderna covid-19 vaccine 100 mcg; wrong vaccine administered; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received full dose of moderna covid-19 vaccine 100 mcg) and WRONG PRODUCT ADMINISTERED (wrong vaccine administered) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D NOS for an unknown indication.    On 05-Nov-2021 at 7:55 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Nov-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 05-Nov-2021 at 7:55 AM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received full dose of moderna covid-19 vaccine 100 mcg) and WRONG PRODUCT ADMINISTERED (wrong vaccine administered). On 05-Nov-2021 at 7:55 AM, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received full dose of moderna covid-19 vaccine 100 mcg) and WRONG PRODUCT ADMINISTERED (wrong vaccine administered) had resolved. In November 2021, VACCINATION SITE PAIN (sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) Normal. On an unknown date, Heart rate: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received full dose of moderna covid-19 vaccine 100 mcg) and WRONG PRODUCT ADMINISTERED (wrong vaccine administered) to be related. No further causality assessment was provided for VACCINATION SITE PAIN (sore arm).    No treatment information was provided. No concomitant medication was provided. The vaccine clinic was supposed to give the Pfizer vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 14-Nov-2021: Significant follow-up-event updated
Information has been received from a physician concerning a 6 yr old white female who on 28Jan03 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (lot 641162/0797M). There was no concomitant medication. It was noted that the vaccine was stored in a refrigerator inadvertently. A few days after vaccination, on approx 31Jan03, the pt developed a break through case of chickenpox. Lesions were on her face and it was less than 50 lesions. Unspecified medical attention was sought. Subsequently, the pt recovered. A product quality complaint was not involved. Follow up information was received from the physician's office which indicated that the pt had chickenpox, just a few, in Feb 2003. The pt recovered on an unspecified date. No further information is expected. It was reported that the pt's female sibling also developed breakthrough chickenpox after therapy with varicella virus vaccine live. (WAES0511USA02330).
healing a wound in the hand; She had adverse reaction to the main vaccination; This spontaneous case was reported by a consumer and describes the occurrence of WOUND (healing a wound in the hand) and VACCINATION COMPLICATION (She had adverse reaction to the main vaccination) in a female patient of an unknown age 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 WOUND (healing a wound in the hand) and VACCINATION COMPLICATION (She had adverse reaction to the main vaccination). At the time of the report, WOUND (healing a wound in the hand) and VACCINATION COMPLICATION (She had adverse reaction to the main vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment medication was reported.
Sever hearing lose, severe ringing and severe vertigo, being treated with prednisone as well as  and anti-viral, valatytlovir hydrochlorothiazide, meclizine.  Doing trouble, no improvement in my hearing, completely gone now and feel like I am going to throw up.
Information has been received from a Certified Medical Assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # K026246, expiration date 28-JAN-2017, dose and route were unknown). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Patient reported a red, raised, quarter-sized nodule approximately 4 inches below the injection site that developed the morning after receiving the vaccine. It was swollen and warm to the touch. As of today, 6 days after receiving the vaccine, the rash is no longer swollen/raised, but it is still red and has expanded to an area about 5 inches wide. The patient's primary care provider was alerted by the pharmacy.
11/07/2022 I had a runny nose which I have all the time because of allergies. When my son tested positive, I tested and was positive on 11/08/22. My symptoms were very mild, I was not very sick. I did not stop working from home. I tested negative a week later. I still have a runny nose, which is probably from allergies.
My arm was sore after getting the shot. About 2 hours after I received the shot I got a headache. Around 1:30am (about 10 hours after shot) I had body aches, chills, low fever, and my headache continued. I felt this way until about 2:30pm (around 24 hours after shot). I continued to be a little sore and tired the rest of the day but felt normal the next day.
About 3 weeks after the vaccine, I started spotting for 4 days. After these procedures I experienced more bleeding.
Pt with h/o class 5 egg allergy developed itching, cough, wheezing within 20 mins of MMR vaccine. Sats decreased to 93%. Pt given Benadryl and Decadron. Sat improved, swelling decreased no Epi given.
Red, warm to touch area below the vaccination site.  Patient states this started the evening she received the vaccine and she experienced some swelling in the arm the following day but now the irritation seems to be lessening.
pt recvd vax 24NOV93 & initially c/o arm soreness & swelling x 4 days, but on 29NOV93 soreness gone & noted red blotchy raised areas on upper lt arm along w/itching; took DPH;
Per Alert, this person received her first Moderna vaccine on 5/06/21 and the second dose on 5/21/21. In Alert profile it says "Not Valid" for second dose, since it was given too early.
2/25/21 reported fever and body aches. 2/26/21 developed rash, over that weekend rash spread and itching developed. week of March 22,2021 employee developed hives throughout body and rash had continued to spread through body.  At this point, started OTC Zyrtec with little to no relief.
Information has been received from a physician concerning a 9-year-old female who in approximately 2004 "about 4 years ago" was inadvertently given MMR II "twice within one week apart" when she was 5 years old. On an unspecified date, it was reported the patient may have developed subacute sclerosing panencephalitis due to the high dose of MMR II. It was also reported the patient is terminally ill and has severe brain damage. On an unspecified date the patient had the following diagnostic labs performed: "MMR positive in the serum and cerebrospinal fluid". At the time of the report the patient's status was not recovered. A product quality complaint was not involved. The adverse events reported were considered to be disabling, life threatening and required hospitalization. Additional information has been requested. 4/28/08-records received for DOS:12/18/07-2/14/08-DC DX: Progressive encephalopathy diagnosis secondary to subacute sclerosing panecephalitis (SSPE). Treated with plasmapheresis for progressive neurological deterioration with decreased motor skills with inability to walk and swallow difficulty.  New on set seizure disorder. G tube placement Treated with IVIG.  During IVIG treatment developed tremor, hypertonicity and drooling. Became unresponsive to verbal tactile stimulus only minimal withdrawal to painful stimulus, comatose state, nonambulatory with positive clonus, hypertonic. Transferred to chronic care facility.
Patient developed hives at vaccine injection site within 5 minutes of receiving vaccine.  Vital signs were assessed after 5 minutes x 30 minutes and remained stable.  No meds given.  No additional hives noted.  No respiratory distress.
Information has been received from a physician concerning an approximately 80 years old female who was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) subcutaneously a year and a half ago. In December 2008, after receiving ZOSTAVAX (Merck), the patient developed shingles with "neuralgia". The patient had sought unspecified medical attention. It was reported that the patient improved but final outcome was not reported. Follow-up information has been received from the physician concerning an 86 year old female who on 02-AUG-2007 was vaccinated with the first dose of ZOSTAVAX (Merck) (lot number 657676/0619U) intramuscularly. Concomitant therapy included many unspecified medications. On 01-NOV-2008 the patient developed shingles with post herpetic neuralgia. Shingles and post herpetic neuralgia were considered to be disabling and an other important medical event by the physician. Additional information has been requested.
Reported apneic x5-7 sec. Vomited x2. Sats 80s in ER. Received epinephrine in ER.
My daughter broke out in welt-like hives 2 hours after an H1N1 nasal innoc. Hives were across her knees and were gone by the next day but she had severe nausea for 2 days.
03-27-08 Phone call from patient's mother, to JMCHD reporting the following information.  Her 4 y/o son received immunizations at JMCHD 10-01-08.  10-08-08 he started coughing had fever around 100 degree.  He continued in pre-school.  10-15-08 symptoms of nausea, vomiting, and staring.  Transported to hospital.  Grand mal seizure in ER.  Admitted to hospital.  10-16-07 Discharged with medication for seizures.  Continued to have focal type seizures as many as 40 per day with duration 45 seconds to 3 minutes.  12-10-07 admitted to JMCGH after grand mal seizure in route to hospital.  12-11-07 discharged from JMCGH.  Referral for evaluation.  01-09-08 Admission to referral.  01-12-08 Discharged from referral.  Mother states child has several behavioral changes and is presently not able to attend pre-school.  6/3/08 Reviewed hospital medical records for 12/9-12/11/2007. FINAL DX: status epilepticus Records reveal patient experienced tonic-clonic seizure x 45 min requiring multiple meds for cessation.  Had runny nose, congestion, cough & had been exposed to sick contact at school.  Improved slowly & d/c to home w/unsteady gait.  Family had antiseizure med on hand from prior seizure 2 mos ago but did not administer at home.  D/C to home w/neuro clinic f/u.  6/3/08 Reviewed hospital records for 10/15-10/16/2007. FINAL DX: new onset seizures Records reveal patient experienced HA, abdominal pain, vomiting, diarrhea & incontinent of urine.  Had staring, left sided tonic-clonic seizures lasting a couple minutes followed by left sided hemiparesis which resolved.  Seen in ER & tx w/meds.  Admitted to PICU.  No further seiures were noted & returned to baseline w/no residual weakness.  Consulted peds neuro.  D/C to home w/meds & peds neuro f/u.   6/3/08 Reviewed Neuro clinic records of 12/2007-2/2008  FINAL DX: intractable epilepsy  Records reveal patient did not have further seizures since starting the meds but had staring spells. Then in January, started having frequent seizures despite medication & was seen again in ER.  Meds changed but continued w/seizures consisting of staring, gasping for air & nonresponsive w/only occasional tonic-clonic activity.  Meds maximized & had improvement to only 2 seizures/day but longer lasting.  Meds possibly caused hyperactivity & ADHD.  Meds changed w/some improvement in hyperactivity.
Again, I don't think it was a reaction to the booster. I think it was an unfortunate timing, that I contracted Covid at the same time as the booster.
Developed chest pain and trouble breathing 2 days after the vaccine. Chest xray showed pneumothorax.; This is a spontaneous report from a contactable consumer (patient). This 18-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 20Apr2021 18:00 in left arm for COVID-19 immunization. There was no medical history. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient developed chest pain and trouble breathing 2 days after the vaccine on 22Apr2021 16:00. Chest X-ray on 22Apr2021 showed pneumothorax. The adverse events result in Doctor or other healthcare professional office/clinic visit. The outcome of event was resolving.   Information on the lot/batch number has been requested.
Information has been received from a nurse concerning a 12 month old female patient with a history of hyperbilirubinemia at birth and no concomitant medication who on Feb 26, 2001 was vaccinated with a dose of MMR II (lot # 635922/0015L). Concomitant therapy on Feb 26, 2001 included a dose of varicella virus vaccine live (lot #1342K not valid for this product). It was reported that the patient was well at the time of vaccination. The patient visited the office on March 2001 for right otitis media. It was also reported that the child was back in the office on March 2001 for a visit and the right otitis media was still present. It was reported that the patient was not hospitalized. Additional information has been requested. The reporter indicated that the patient's sibling also had an experience (WAES0302USA00161).
Vaccine was given to patient and there was no adverse reaction.  Vaccine expiry date was 05/31/2022 and beyond date use was 04/19/2022.  Contacted the patient and they had no side effects.   There was no temperature excursion during the storage of vaccine since the time vaccine was received.
This spontaneous report was received from a nurse and refers to a 4-year-old male patient with congenital heart disease and primary pulmonary hypertension. The patient had no known drug reactions/allergies. The concomitant medications were not provided. On 21-AUG-2015, the patient was vaccinated with the first dose of measles, Oka-Merck PROQUAD subcutaneously (exact dose, lot # and expiration date were not reported) for prevention of measles, mumps, rubella and varicella. There were no adverse reactions after the first dose administration. On 15-OCT-2018, the patient was vaccinated with the second dose of Oka-Merck PROQUAD recombinant Human albumin (rHA), subcutaneously, lot # R014354 and expiration date: 18-NOV-2019 for prophylaxis. On 15-OCT-2018, immediately following administration, he went into anaphylaxis and was wheezing in the office. As a treatment BENADRYL intramuscularly (IM) was given and the patient was on oxygen before the ambulance arrived. In the ambulance the patient got steroids. He was transported and admitted to the medical center to the observation unit on 15-OCT-2018. The outcome of anaphylactic reaction was unknown. The causality assessment between measles, Oka-Merck) PROQUAD and the event was not provided. The reporter considered the event of anaphylaxis to be life threatening. Upon internal review, the event of anaphylaxis was considered to be medically significant because it required treatment with oxygen.
next day, red blotches began to form on arm, followed by inflammation, more show up by the day, fever
In the evening of the second day following the vaccine dizziness and nausea began abruptly at 7pm. The injection site was sore and had been since the time of the vaccine. By 8:30pm dizziness and nausea worsened and I went to bed. At midnight I woke up with diarrhea and experiencing extreme fatigue and muscle soreness over the entire body.  A headache was intense almost like a migraine. Neck and back were sore and stiff. At 1am I returned to bed after taking two extra strength ibuprofen capsules. I did not get up from bed again until afternoon Wednesday to urinate then went immediately back to bed with zero improvement in symptoms except diarrhea was gone. Remained in bed throughout the rest of Tuesday sleeping all but 2 hours total. This remained the case through Thursday morning. I went to the urgent care/ER to get tested for COVID and other viral panel to determine if this was a vaccine reaction or something else. Friday morning following all symptoms were gone completely. No feeling of residual illness of any type persisted into Friday at all. Since I?ve never ?recovered? completely from any illness so suddenly, it seemed to further indicate the symptoms were a response to the vaccine and not any actual viral or bacterial source. This was my 5th COVID vaccine injection and I?ve never had a reaction to any of them other than temporary injection site soreness.
Initial unsolicited report received from a health care professional on 7 August 2015. A female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (batch number, dose, route of administration and site of administration were not reported) on an unspecified date. On an unspecified date, 2-10 days after vaccination, the patient experienced shingles last year. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
First 2 days: fever 101.5, whole left side pain, abdominal pain, headache, lower right leg pain  3rd day: low grade fever 100.5, lower right leg pain, left arm pain  4th day: lower right leg pain increased along with redness, swelling, red lines, and eventually I couldn't apply weight on my right leg. After visiting Urgent Care hospital, blood clots were found in my small veins.
Began covid-19 symptoms on 06/08/2021 and tested positive for covid-19 on 06/11/2021
really sick; headaches; felt terrible/ not feeling good; throat started to feel funny; couldn't swallow; It felt like it was swelling shut; tired; her arm hurt; This is a spontaneous report from a contactable consumer (patient) reported for herself. This 56-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine, lot number: 301358A) via an unspecified route of administration on 17Sep2021 at 18:00 as single dose for COVID-19 immunization. Medical history included anaphylaxis and allergies, Covid twice: the first time was in Oct2020 - she was sick for a week and on day 8 she had a fever and went to the ER, but she was not hospitalized. The doctor told her she had pneumonia after an xray of her lungs with crackling and she was given antibiotics. On 20Jul2020 she went to the doctor and was tested for Covid, and she had antibodies as well as tested for Covid and it came back positive on 27Jul2021. She had no symptoms but was still told to quarantine. She did two nasal swabs afterwards that came back negative. The second time she didn't even know she had it, they checked her for antibodies, but she was tired of dealing with quarantine. Concomitant medications were unknown. The patient received her first dose of the Pfizer BioNTech Covid 19 vaccine on 17Sep2021 at 18:00. She had a history of anaphylaxis and allergies so she waited 30 minutes. She had no problems at first, but in general she was not feeling good that day or anything. She was tired and her arm hurt on 17Sep2021. That night, she was eating pretzels, around 8-8:30PM her throat started to feel funny like she couldn't swallow, almost like strep. It felt like it was swelling shut, but she could breath. She was still scared. She took Benadryl, and stayed up all night Friday. The next day she was really sick on 18Sep2021, and had terrible headaches that lasted through Sunday. She felt terrible on 18Sep2021. Today she was fine. She will have to go back for the second Pfizer Biotech COVID shot in Oct2021, but she was really afraid. She was tired of dealing with it. She didn't think she's going to get the second dose. Her pharmacist couldn't tell her anything and her doctor told her it could be worse or it could be nothing. So the second vaccine may not give her any side effects, but other times it can be worse. She was leaning towards not getting the second shot but wanted to know if there's any information available on if the second dose will be worse than the first.   It was reported that side effects after the second shot may be more intense than the ones the patient experienced after the first shot. These side effects were normal signs that her body was building protection and should go away within a few days. Outcome of the events really sick and felt terrible/ not feeling good was recovered on 20Sep2021, of the event headaches was recovered on 19Sep2021, of the other events was unknown.   Follow-up attempts are completed. No further information is expected.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Pt called our store stating he had severe headache and vomiting. I called pt. he believes he is having a reaction to vaccine. He's at ER 2:00pm.
No adverse events. Patient got her Moderna booster dose outside of the recommended parameter. At time of injection, patient has told us that it has been at least 6 months since her 2nd dose. Pt forgot her covid vaccination card at the time so she brought it in later for us to document her booster shot. That's when we realized that it has only been 5 months since her 2nd dose.
Vitiligo - clear loss of pigmentation on hands and other places  Never had this before.  No family history that patient knows of.  Waiting for treatment options, dependent on approval by insurance company (which currently is refusing to cover).