chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm (at the injection site); This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   The reporter considered the injection site pain to be unrelated to Shingrix.  Additional details were provided as follows: This case was self-reported by the patient. The patient received 1st dose of Shingrix in the left deltoid and experienced injection site pain. The patient had her routine physical checkup in May 2021. The patient did not know if the shot was given intramuscularly. The patient said that doctor's office did not think her symptoms were due to Shingrix. The patient did not have information about lot number and expiration date. The patient did not receive any paperwork from pharmacy. The patient did not want to provide her doctor of medicine (MD) contact information. The reporter did not consent to follow up. For the tolerance of 2nd dose, refer case US2021AMR185129.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR185129:Same reporter.
12/18/2020 5 MINUTES AFTER INJECTION, FELT HOT. TEMP KEPT GOING UP. TEMP WOULD NOT GO DOWN. STAFF PUT COLD PACKS ON  ME. ITCHING STARTED BUT NO RASH VISIBLE ON ARMS AND BACK. DR. STATED TIME TO TX TO ER. THE HEAD HAD INCREASED EVEN MORE. COULDN'T BREATHE DEEPLY, 'AIR STOPPED', COULDN'T SPEAK PROPERLY. PREDNISONE, ANXIETY AND BENADRYL ADMINISTERED. MONITORED O2 STATES, MONITOR HEART.  AT HOME BODY STARTED TO ACHE, NOT MEDICINE TYPE PERSON. HELD OFF TILL 1AM, TOOK 2 TYLENOL 500MG. BY 3 AM ABLE TO SLEEP. HEAT SENSATION WAS STILL THERE. BY 12/20/2020, INJECTION SITE SORE, LUMP. I WAS TIRED. BY 12/21/2020 THE SITE WAS SORE, I RUBBED WITH ALCOHOL. PROBLEMS WITH SWALLOWING, EATING GINGER CANDY TO HELP WITH DRYNESS. THROAT BOTHERS AFTER TALKING, TIGHTENING.  DR. STATED AT 2ND  INJECTION WILL PROVIDE THE BENADRYL, PREDNISODE, AND ANXIETY MEDS 30-60 MINUTES BEFORE ADMINISTERED. 'I DO BELIEVE I NEED OTHER SHOT TO BE COVERED'.  'CLOSE TO ER FOR SECOND SHOT'.  I DO HAVE PROBLEM WITH VACCINATIONS; I GET INTO TROUBLE. MY BODY HAS REACTIONS, TROUBLE BREATHING.  'SOLE PROVIDER FOR WHOLE FAMILY; I HAD TO TAKE THE SHOT' 'FEELING ABOUT 100%'
Not sure if this qualifies under vaers but just trying to ensure he is alright and unsure to see if he needs medical attention. However, we are certain and concerned with a swollen clot at the area of vaccination ( lateral side of Left Arm below shoulder) , limiting his limb movement such as ability to lift,  move, rotate, pain to touch. it's hard in the spot. We are gonna wait  for 2 more days before visiting primary care physician.
On the day of the immunizations, shortly after receiving them, I began having severe pain directly in my groin area approximately 15-20 minutes after the shots were administrated. I also felt light headed and my arm began to slightly swell. After 24 hours the arm where the immunization were given began to throb and swell slightly more: the pain became almost unbearable to the touch. I began range of motion on my arm continuously trying to work the medication in but nothing worked at that point. Fast-forward two weeks later my arm is extremely hot to the touch and throbs terribly. Now, my arm has swollen immensely.
The pt received vaccine on 5/4/00. Pt states pain in arm at site of injection on 5/4, redness and pain on 5/5, and swelling, pain and redness on 5/6. The pt states a headache and fever on 5/5 and 5/6, ice provided some relief. Erythema and edema extends past elbow and area of swelling still growing. Per phone conversation with health department, this sounded like a severe (and abnormal) local reaction. Pt had an appt with PMD, but was told if symptoms worsen go to ER.   Follow up states the pt saw PMD was given Levaquin, Prednisone and instructed to apply ice. Was also instructed to never receive TD with animal growth again.
Started as red swollen lesion at right thigh site, no fever, no problems with walking. Now with depigmented area with depressed area measuring 2 1/2 x 1 1/2 cm. Redness noticed on 1st day after injection- depigmentation started on 4/24/04
This 71 year old male received the Covid shot on  3/26/21    and went to the ED on  4/21/21     and was admitted  on 4/21/21 with the following diagnoses listed below. I21.4 - Non-ST elevation (NSTEMI) myocardial infarction N17.9 - Acute kidney failure, unspecified D69.6 - Thrombocytopenia, unspecified Fever  Vomiting
Pt was seen in office for 11 yr wcc @ 2:45pm  by Dr.  11 Year vaccines were requested & given at 3:30pm- TDAP, MENVEO & HPV. Pt "felt dizzy" immediately after vaccines were given and was instructed to lay down on the exam table & drank a cup of water. Asked pt what they ate today & stated they ate before they came in to office. Pt sitting up on table and observed for 15 minutes to assure safety. Pt stated he felt "good and was not dizzy"when the 15 min was up. at 3:45pm.  Walked to receptionist desk and told mom he was startng to "feel dizzy" again. Myself, a co-worker and mother slowly lead patient to the floor as he "passes out". Pt walked back to room to lay on exam table and had more water  &was offered 2 packages of crackers as he admitted he only ate ice cream all day today. Pulse 83 & BP  92/50 was obtained once in room & normal. Dr. reassessed pt to assure safety. Pt laid on exam table for another 15 minutes to be observed and finished both packs of crackers. Pt then stated he "felt better and was not lightheaded or dizzy- just hungry" after the 15 minutes was up. Encouraged to call with any concerns or questions.
Flu like symptoms; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Tired). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, CYP2C19 gene status assay: unknown (Inconclusive) Ultra Rapid Metabolizer.         Other Lab data: Her reports states that she has CYP2C10*7 (p-806C7T). Treatment products include topical hydrocortisone on the rash and took zyrtec initially but then switched to Benadryl. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-062225 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062225:First dose case
nausea started at 7 pm - 5 1/2 hours after vaccine vomiting started at 8:30 pm, lasted until 9:30 - vomiting was accompanied with chills.  diarrhea started about 10:30 pm and lasted until 6 am on April 11th.  general feeling of fatigue for 12 hours on April 11th.
Client received dose of Janssen COVID 19 vaccine after denying (on written documentation form and verbal confirmation of written documentation during nurse interview) having received any previous COVID 19 vaccinations. Upon entering vaccine administration into website, documentation of previous vaccination discovered. Moderna COVID 19 dose one 0n 05/17/2021  lot # 040B21A and dose 2 on 06/14/2021 lot # 025C21A at Clinic. Questioned client regarding previous Moderna doses. Client again denied previously receiving COVID 19 vaccinations.  Dr., regional medical director for notified of occurrence. No further orders received.
I received my vaccine on 12/31/2020, that evening I had redness, swelling, and heat at the injection site.  It went away by the 3rd day. On 1/8/2020 the redness, swelling, and heat at the injection site returned. The area is tender to the touch.  I've taken Ibuprofen and will use an ice pack for the localized reaction.
DEATH; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death. It was reported that, the patient death occurred after receiving the vaccine. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked.; Sender's Comments: V0: -covid-19 vaccine ad26.cov2.s-death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patient asked for flu and pneumonia, but she has already received the vaccine on 9/28/23. The flu shot was processed and administered. She has currently not reported any adverse events from the second dose of flu vaccine.
pt recvd vax;approx 24 hrs later,exp generalized hives(chest,back,inside elbows,back of knees,thighs)which were tx w/ dph;hives ranged from 10cent to 50cent sized raised welts & lasted  48-72 hrs;exp also sl low grade feverr 99.8-100.2;
Dizziness, weakness, injection site welt, chills, body aches, headache
Information has been received from a 62 year old female consumer with no reported history or allergies who on 18-SEP-2006 was vaccinated with a dose of Zostavax. Concomitant therapy included Famvir. The patient had no skin reaction to the vaccine, however on 30-DEC-2006 the patient started experiencing pain in the center of her chest that was "so bad she couldn't even go to her physician's office". Two days after experiencing the pain, she started having breakouts with approximately 30 lesions in her spine area and up to the front. As of 17-APR-2007 the patient has recovered and she has had no outbreaks anymore. The only thing she was experiencing was sunburn like pain in her back. It was reported that the patient was seen by a dermatologist to verify the skin rash and for a "stressed test" (results not provided). There was no product quality complaint involved. Additional information has been requested.
Moderna COVID-19 Vaccine EUA Slightly itchy rash around the injection slight, 7 days after receiving shot. Rash is approx.  the size of a credit card and only around the injection site.
Patient presented to our office with left facial weakness noted with diminished left nasolabial fold and weak upper lid. I diagnosed her with Bell's palsy.
Patient got really hot and started sweating and claimed her heart was racing. She then had trouble standing up and slid to the floor. Both of these happened about 5-10 minutes after the immunizations. EMT showed up and said she had a low blood pressure and then they were going to do an EKG on the ambulance since the daughter did say that she had heart issues.
Had normal irritation at the site of injection. Felt sick and weak all week. saw a Doctor on Sunday and tested negative for covid.
Patient given a flu shot in right arm and a pneumonia shot in his left arm on 10/29/08.  Wife called and stated patient had swelling and extreme soreness in left arm.  Follow up call on 11/1/2008, patient no longer has soreness and did not require any further medical care.
No additional AE; expired dose of MMR II was administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, drug reactions/allergies or concomitant therapies was provided.   On 23-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), 1 dosage form, lot # S013536, expiration date 02-MAY-2021 (route of administration was not provided) for prophylaxis. No adverse event was reported.
Patient had acute onset of fever and became hypotensive, bradycardic, and slow to respond.
On the day of the vaccine at 06:00 pm I was fatigue. On the 02/19/2021, when I woke up I had very heavy legs and dizzy. After that I was in a complete tailspin of being dizzy all the time and blood pressure spikes, but mainly dizzy. Every time I was driving to work, I was dizzy. I had to get help to get out of the car. Once I got out of the car it was activated again. I felt like if I pressed on my pulse points it would feel better. I applied strips of tape on lymph nodes around my neck and on my wrist and it made me feel better. And I had rapid heartbeat the whole time. I was coming home and going straight to bed because I was exhausted. At work I was mean and nasty which is not like my character. I felt like I was drug induced. The only way I would feel better was to try to eat and drink. I drove myself to the Emergency Room in March, and I told them I was having a stroke or heart attack and I was dizzy. My heartbeat was really fast all the time. They took CT scans, and everything was normal. They prescribed meclizine at the ER, it made me feel sleepy, I only took one that they gave me at the hospital. It lasted like this until April 20, 2021, it subsided on its own. Like I woke up from the end of the side effects of the vaccine. The emergency room doctor advised me not to take the Moderna Dose 2.
Pharmacist is reporting that a patient received VARIVAX Intramuscular route instead of subcutaneous route.; This spontaneous report was received from a pharmacist, referring to a 29-year-old female patient. The patient's pertinent medical history, previous drug reactions, allergies and concomitant medications were not reported.   On 28-SEP-2020, at the age of 29-year-old the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX), by intramuscular route instead of subcutaneous route (incorrect route of product administration) (formulation, strength, vaccination scheme and anatomical site of vaccination were not reported; lot number T012551, which has been verified to be valid, expiration date reported and validated as 10-APR-2022) as prophylaxis.
Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, RHINORRHOEA (Runny nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication was reported.  No treatment medication was reported.  The patient wants to know about the  booster shot of Moderna COVID-19 vaccine.
Pt reported flushing/sweating, dizziness, head pressure. Vitals: 152/106, 83, 18, 99% RA -- > 147/102 Pt AxOx3.  Per pt, BP is at his BL.  Instructed pt to f/u w/ PCP regarding BP.  Pt states that he feels ok to drive home.  Pt ambulated w/ steady gait.  Not changes notes.  Per clinic lead pt ok to drive home w/ instructions to call EMS if symptoms worsen.  Pt given juice and crackers.  Pt states that he feels better prior to departure.
Sore at injection site; This is a spontaneous report from a non-contactable consumer (patient). This 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318), via an unspecified route of administration in left arm on 16Feb2021 at single dose for COVID-19 immunisation.  Medical history was none. No known allergies. Patient was not pregnant.  The patient's concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Lot Number: EN5318) on 26Jan2021 for COVID-19 immunisation. The patient experienced sore at injection site on 17Feb2021 with outcome of not recovered.  No treatment received. Patient did not have COVID prior vaccination, did not test COVID post vaccination.   No follow-up attempts are possible. No further information is expected.
Extremely high fever (105 +) that lasted for six hours and caused delirious speech. Extreme muscle pain for four days. Low grade fever for four days. Deep bruise and pain at injection site - still bruised. Extreme fatigue for three days. Flu-like symptoms for five days. Today, six days after SHINGRIX vaccination I have a cold sore on the corner of my mouth. First cold sore I've ever had in my life!
"Moderna COVID19 Vaccine EUA"  Hospitalized for weakness vomiting and diarrhea. suffered a fall after getting dizzy and syncopal episode
Administered booster dose of Moderna (Blue top).  Person should have received Bivalent booster (blue top).   No adverse event occurred.
Dose #1, 0.2 ml,  of Pfizer pediatric vaccine (maroon cap, ages 6 months -5 years) was administered without dilution.  As can be determined, the patient received approximately 36 mcg instead of 3 mcg.  Upon examination by the child's pediatrician, no acute adverse effects were noted at this time.
Caught COVID from mother who tested positive 12/30/2021 with her first symptoms appearing 12/27/2021.  Initial symptoms (12/31/2021): sore throat, runny nose, sinus pressure. Later (1/6/2022) ran 99.9F fever intermittently with severe fatigue, headache, and cough. Cough (1/15/2022) and fatigue (1/20/2022) continued for several days ending on the dates noted.
AFTER RECEIVING THE VACCINE, PATIENT WENT TO SIT DOWN FOR THE 15 MINUTE OBSERVATION PERIOD. SHE WAS FEELING FAINT AND FELT LIKE SHE WAS GOING TO PASS OUT. SHE FELT NAUSEOUS AND VOMITED ON THE FLOOR IN THE WAITING AREA. SHE REPORTED TINGLING IN THE HANDS ALSO. EMERGENCY SERVICES WERE CALLED AND SHE LEFT WITH HER FATHER TO GO TO THE HOSPITAL TO GET CHECKED OUT.
Diarrhea for two weeks; Chills for a week; Felt lethargic for one week; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHOEA (Diarrhea for two weeks), CHILLS (Chills for a week) and LETHARGY (Felt lethargic for one week) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea for two weeks), CHILLS (Chills for a week) and LETHARGY (Felt lethargic for one week). At the time of the report, DIARRHOEA (Diarrhea for two weeks), CHILLS (Chills for a week) and LETHARGY (Felt lethargic for one week) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Site: Itching at Injection Site-Mild, Systemic: Body Aches Generalized-Severe, Systemic: pain in hip that radiates down his leg..pain at a level 8..pain that switches from both sides of body-Severe, Systemic: Joint Pain-Severe
Received pneumococcal vaccine 02/21/07 at left upper arm. Mild febrile episode 07/22/08. Swelling, erythema, vomiting, fatigue on 07/23/08 (fever 104.3), seen at ER given BACTRIM 1 tsp BID, MOTRIN 2 tsp every 8 hours.
received the recall batch of Shingrix that GSK issued on 02/10/2021; received the recall batch of Shingrix that GSK issued on 02/10/2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number TT2JF, expiry date 28th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received the recall batch of Shingrix that Glaxosmithkline issued on 10th February 2021. The reporter stated that, the lot number was not 9LH3Y and was not sure if this the lot number from one of the vials. The reporter stated that, the vaccine was administered to the patient before the recall of drug. This case was 1 of 8 linked cases, reported by same reporter for different patients. The reporter consented to follow up via email.
Rash developed about 12 hours after receiving 9/16/03 shots. Feet were swollen worse on next morning. Thousands of tiny bumps on tops of feet. ? over body except rash spread to scalp, palms and sides of feet; not hives but raised.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 16 years old female patient. The patient was vaccinated with dose 1 GARDASIL on 20-JUN-2012. Other suspect therapies included VARIVAX (Merck) on 20-JUN-2012. Concomitant medications included BOOSTRIX, HAVRIX and MENACTRA. On 20-JUN-2012 the patient experienced dyskinesia, 1 day after onset of therapy and dizziness. No treatment information was reported. The outcome of dyskinesia and dizziness is unknown. The relatedness for dizziness is unknown for GARDASIL. The relatedness for dyskinesia is unknown for VARIVAX (Merck) and GARDASIL. Additional information is not expected.
A nurse reported that a 37-year old female received an injection of flu shield (2001-2002 Formula) on 19-Nov-2001. Approximately 7 hours post-vaccination, the patient developed swelling and a rash at the injection site. She was treated with Benadryl (diphenhydramine) and prednisone.
11 hours following vaccine woke with slight throat constriction, plugged ears, and extra mucus/mild respiratory distress. This is commonly my first sign that anaphylaxis May develop. Took 1 reditab Claritin, which sometimes helps. Symptoms continued and took 3ml Benedryl which is my second step for calming rxn - this worked. My history is that anaphylaxis rxns can increase overtime with more exposure. This same progression happened with Botox & 4th rxn was much stronger and have not had since.  Today symptoms are similar to previous post-vaccine symptoms: headache, fatigue, injection site soreness, achy, and unsure if fever & chills will develop later today (they did for last two Covid vaccines)
non itchy rash starting on R arm and spreading to neck, chest, and L arm, so far lasting 10 days