chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hurting/pain/ it only hurts with movement; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 47-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On 11th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than 3 months after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The patient was an employee and she quickly reported the adverse events to the nurse practitioner. The patient received Fluarix in her right arm. The patient's arm was still hurting where she got the shot. She had no swelling and no discoloration and it only hurts with movement. No additional details were provided. The reporter consented to follow up. This case has been linked with US2019209098 and US2019209636, reported by the same reporter.
Patient received Flu and Pneumonia shot in left deltoid. Arm became extremely swollen and painful. Patient was told to seek medical advice. Patient was placed on Augmentin 500mg and moist heat and Tylenol.
CMA administered 0.2ml of Pediatric Pfizer Covid 5-11 orange top vaccine that she did NOT reconstitute before administering.  Proper protocol was not followed.  Medication Error occured.   Parent was notified of the error.   Child had no immediate adverse reactions as a result.   Parent was instructed to follow the printed handout guidelines for care that were given to her and to follow up with medical care if child reacts severly or unfavorably.  Follow up phone call was made the next day to ensure patient was still doing well.  Parent reported that child was well and attending school with no more that a little soreness in arm.   No further reports of reactions at the time of this report. Support was provided to the CMA who is 3 months into position and was given immediate  retraining and at the elbow support to assist for all future vaccines.   CMA will attend a refresher course in Medication Administration.  Vaccine Safety Nurse was notified of incident and support.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-JUL-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Chills started at 10pm on 3/10/21 Woke up very achy, weak & a  bit short of breath  No energy at all ALL day! Slept off & on all day.  No appetite.  Most symptoms went away by 9pm on 3/11/21
This was administration error.  Vaccine was administered on 9/6/22 and had expiration date of 8/31/22.
Symptom of sore throat started 12/28/21 and continued until 12/31/21.  Accompanied by fever, cough, aches, fatigue, loss of smell and taste on 21/30/21 for about 18 hours.  Still currently feeling fatigues and coughing.
Feeling typical side effects:  fatigued, achy all over body, nauseous, and elevated temperature. However, my heart rate has been elevated over the past 24 hours ranging from 105-125 bpm. This started one day after (March 23rd) the 2nd vaccine was administered. My heart rate has decreased slightly, but still around 100-105 bpm as of Wednesday, March 24th at 6:30am. I am mostly concerned about the elevated heart rate since I have not seen this as a side effect.
This spontaneous report was received from a nurse practitioner and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On an 17-MAY-2018, the nurse noticed that 2 syringes in the GARDASIL 9 box (NDC 0006-4121-02, lot# N029069 with an expiration date 17-MAY-2020) had a different unknown NDC, lot and expiration date (NDC 000064121-01, lot# M743R56 with an expiration date 02-JAN-2003). On the same day, the patient received GARDASIL 9 with correct NDC number, lot# and expiration date (dose, route of administration was not reported) for prophylaxis. The GARDASIL 9 with the incorrect NDC, lot#/expiration date was not administered, and the remaining 8 doses in the box that had the correct NDC, lot# and expiration date were administered. No adverse effects was reported. Product quality complaint (PQC) was reported. Lot number M743R56 is an invalid lot number for GARDASIL 9. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1806USA005991:
Reported bruising, swelling, drainage, pain after a couple of days after getting Flu shot at doctors office - Pt also had Protimes done same day. Pt being followed by PCP due to swelling.
Pt called clinic with c/o unable to lift arm. Gradual onset since 10/15. Went to ER 10/23 put on steroids and pain meds, X-rays neg.
Felt weak; Neuropathy; hot skin all over; skin burning; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak) and NEUROPATHY PERIPHERAL (Neuropathy) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ASTHENIA (Felt weak) (seriousness criterion hospitalization), FEELING HOT (hot skin all over), SKIN BURNING SENSATION (skin burning) and PRURITUS (itchiness). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant). At the time of the report, ASTHENIA (Felt weak), NEUROPATHY PERIPHERAL (Neuropathy), FEELING HOT (hot skin all over), SKIN BURNING SENSATION (skin burning) and PRURITUS (itchiness) had not resolved.            Treatment Medication was cortisone cream, cerave, and Citalopram.  This case concerns a 91-year-old female hospitalized with serious unexpected events of peripheral neuropathy and asthenia, along with nonserious unexpected skin burning sensation, feeling hot and expected pruritus.  Event onset Day 2 after second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 91-year-old female hospitalized with serious unexpected events of peripheral neuropathy and asthenia, along with nonserious unexpected skin burning sensation, feeling hot and expected pruritus.  Event onset Day 2 after second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Nausea, vomiting, diarrhea within about 3 hours of 6th vax in series.
site hot, red swelling, size of 4cmx4cm tennis ball, left arm upper noticed. 1/25/07 seen in office 1/26/07
Fever, chills, severe body aches, headache, abdominal pain, nausea, insomnia
This case was reported by a nurse via sales rep and described the occurrence of weakness in a 82-year-old male patient who received TWINRIX for prophylaxis. On an unknown date, the patient received the 1st dose of TWINRIX. On an unknown date, 1 day after receiving TWINRIX, the patient experienced weakness, runny nose and cold symptoms. On an unknown date, the outcome of the weakness, runny nose and cold symptoms were unknown. It was unknown if the reporter considered the weakness, runny nose and cold symptoms to be related to TWINRIX. Additional details were reported as follows: The age at vaccination was not reported. A day after vaccination, the patient experienced weakness, runny nose and cold symptoms. The reporter agreed to be contacted for follow up.
Pt was schedule for a 6 month booster dose and after receiving his pfizer vaccine nurse noticed that his original series given was moderna and not pfizer. Pt did not have any reactions at the time of injection and still doing fine.
I passed out in the mall next day and had seizure, was taken to ER where I had cat scan and other tests and have severe cut on my tongue from biting it during seizure.
Pt contacted the vaccine healthcare center for evaluation of possible adverse events following the anthrax vaccine. This pt was activated on Feb 10, 2003 and received AVA #1 on 06Feb03 along with the influenza, meningococcal, and typhoid vaccines. He was clinically well at the time; his longstanding hypertension was controlled with medication and his chronic low back pain was asymptomatic. Afterwards he remembers no local reaction but experienced flu-like symptoms for 2 days which resolved with over the counter medications. (note: pt states that he had previous anthrax vaccine doses but there this is not documented) On 21Feb03 he received hep B #1 with no adverse reaction. On 20Mar03 he received anthrax vaccine #2 with no local or systemic reaction. He was deployed  on 15Apr03 and received anthrax vaccine #3 on 16Apr05. Within 4-5 days he reports experiencing migraine headaches 2-3x/ week and having joint and muscle pain with intermittent spasm. His pain was in the hips, knees and elbows bilaterally and it occurred daily. Some days worse than others. He performed all duties and did not seek medical care. He took ibuprofen which was effective the pain for a few hours. At this time he was also taking doxycycline for malaria prophylaxis. In Jun03 he was in a motor vehicle accident and sustained injury to his back. He developed increased low back pain with radiation down the right leg rated at a 8/10. This trauma also triggered a 4 day continuous migraine. He sought medical care and was given Flexeril and Motrin and placed on light duty for 5 days. Pt reports his migraine headaches, arthralgias and back pain have continued to the present. In Apr04  he returned for his post deployment health screening forms documenting weakness, headaches, swollen, stiff or painful joints, back pain, muscle aches, dizziness, difficulty breathing, still feeling tired after sleeping, difficulty remembering diarrhea and ringing in the ears. Pt's back pain has since been evaluated in Apr04 and he underwent physical therapy which has not been beneficial. He is currently being evaluated  for his back pain and has been given intradural injections. In May04 he started evaluation for snoring and awakening from sleep with a sensation of choking and gasping for breath. He was diagnosed with moderately severe sleep apnea and prescribed CPAP. He was unable to tolerate this treatment and was submitted for a medical board and determined unfit for duty. In Nov 04 he self initiated evaluation and subsequently has been placed on medication for recurrent nightmares and insomnia. He also self referred to health center and subsequently received and MRI of the brain and a consult to neurology for migraine headaches. He is scheduled for attendance in the specialized care program beginning 30Jan05.
Warth; Lump Hard Red swollen, about 2 inches Round ARM soreness
Pt got a rash on her arm. It was bumpy and red at times. It seemed to flare up when she got hot.  Eventually, it spread to her chest and back as well. It was treated with benedryl cream and tablets at first, and later with zyrtec and an ointment that the doctor prescribed. It is finally clearing up and nearly gone.
SOB, heart arrhythmia, slight nausea.  Seen by EMT on site.  BP 180/90, Afib on EKG, (None seen on 12 lead), lungs clear, O2 sat taken (no comment from EMT), Glucose checked, lungs clear.
Information has been received from a nurse concerning her 6 year old daughter who two years ago, in March 2008, was intramuscularly vaccinated with a dose of VARIVAX (Merck). The within two months after receiving the VARIVAX (Merck), in approximately May 2008, the patient developed a rash on her leg at the injection site that was diagnosed as shingles. No lab tests were performed. The patient sought medical attention by an office visit. The patient was treated with an antiviral medication. On an unspecified date, the patient had recovered. No further information is available.
This spontaneous report as received from a consumer refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. On an unknown date the patient experienced rash. The outcome of rash is unknown.
Severe shaking, chills, headache, nausea, radiating soreness and arm stiffness in injected arm, 102.5 fever.
After COVID vaccine was administered, the patient began to complain of onset headache, and top of head was tingling. Then the patient began to have a sever deep non productive cough.  All vitals were checked and all appeared to be normal for the exception of his blood-pressure which was very high and blood sugar was elevated (he reported to have ate 2 small donuts prior to arriving for the vaccine.) Patient did not have fever, Patient denied throat/airway swelling and his lungs were noted to be clear.
Intense heart pounding/banging after exercise; highly swollen ankles for 5 weeks.
Pt rec ZOSTAVAX 5/8/14. Pt presented with several small swollen areas (size of small peas) in injection site area on 5/11/14.
Client presented for second dose Moderna. Nurse attempted to inject 0.5 mL dose into clients arm but syringe would not deploy.  Estimates 1/8 of dose given.  With client's permission, they were revaccinated with full 0.5 mL dose without incident.  Syringe used was Magellan Blue from CDC supplies kits
She thinks there has been more anaphylactic reactions than usual and said that a physician female friend had experienced one; This is a spontaneous report from a non-contactable Other Health Professional via Pfizer sales representative. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. During a conference call, (Name) mentioned that she thinks there has been more anaphylactic reactions than usual and said that a physician female friend had experienced one. It was unclear whether it was after a Pfizer or Moderna vaccine. She did mention that her friend recovered without any issues. Outcome of event was recovered on an unspecified date.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
respiratory distress w/in 24 hrs recvd treatment (emergency), asthma persisted for approx 10 years & is still not gone today;
This spontaneous report as received from a licensed practical nurse, refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. The nurse reported that on 01-DEC-2016, the patient was given an improperly stored dose of VARIVAX (lot #M024683, expiration date: 18-MAY-2018; dose and route of administration were not provided). No adverse effect reported. Temperature excursion details: Data logger was involved Temperature: -12.63 *C Time frame: 11 hours 45 minutes. Previous temperature excursion? No. Additional information has been requested.
Patient received full vaccination several months ago but tested positive for Covid-19 this week. Experiencing loss of smell and mild cold symptoms.; Patient received full vaccination several months ago but tested positive for Covid-19 this week. Experiencing loss of smell and mild cold symptoms.; This is a spontaneous report from a contactable consumer (Pfizer employee). A 42-year-old male patient received the first and second doses of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot numbers: unknown) via unspecified routes as single doses on unspecified dates for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not have COVID-19 prior to vaccination. It was unknown if patient received other vaccines within four weeks of the COVID-19 vaccine. It was reported that patient received full vaccination several months ago but tested positive for COVID-19 this week on 04Aug2021. Patient was experiencing loss of smell and mild cold symptoms. Adverse event start date was reported as 02Aug2021. Patient received a PCR COVID-test post vaccination via nasal swab on 04Aug2021 with result Positive. There was no treatment received for the events. The outcome of the events was recovering.   The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Left leg red and swollen. Hydrocortisone started on 03/16/2012.
After having NO reaction for 8 days, I experienced a slightly itchy rash at vaccination site. It lasted for about 2 days. It was slightly warmer than surrounding area.  Comment: Not sure if vaccine was properly administered. It was almost half-way down to my elbow, possibly in the tricep area. I mentioned it to my nurse practitioner during a telemed visit which had  been scheduled before my vaccination. When I showed her photo of my arm with the bandaid, she thought it might not have been placed high enough on the arm. Based on location, not sure if subcutaneous or intramuscular.
Pt received a total of 3 vaccines. First MCV, second FLUZONE, and lastly HPV #1. Immediately after HPV, pt stated, "I am feeling lightheaded". Pt demonstrated vasovagal, paleness. Pt was placed in a supine position. Pt  responded to voice. Pt was given juice, was observed for 20 minutes after event. Pt's mother present. After juice and rest, pt's face color came back and denied lightheadedness, nausea, vomiting, headache. Pt discharged home with mother.
Immediately upon 2nd injection patient became pale and incoherent also making seizure like twitches.  Code green was paged and Nurse practitioner arrived to assess patient.  911 was also notified and an ambulance was dispatched.  Upon assessment from the NP patient was becoming more coherent and vitals stabling with a BP pf 102/60.  Patient was provided crackers and water.  EMS arrived but patient refused transport.  Patient also requested HPV vaccine to be given after incident and was told by NP that was acceptable.  Patient was laid down on exam table and given HPV vaccine while EMS present.  Patient tolerated HPV vaccine without difficulty.
Fever 102F the night that child received the 6 vaccines. Tylenol given by mom Q4h. It only worked for 20 minutes. The baby had shaking episode every 2 hours last about 2 minutes. Only consumed yogurt and unable to tolerate baby milk.
child lost consciousness about 3-5 min after vaccine administration. child collapsed from a standing position and hit his head on the floor. child was awake but not responsive to directions or commands. 911 was immediately called.
I was 7 weeks pregnant and assured by everyone that it would be safe to get vaccinated.  I have had one healthy pregnancy 10 years ago. I found out I miscarried yesterday (4/13/21). I can?t help but feel that it was related to the vaccine & am devastated. I don?t  want any other mothers to experience this if it was indeed related so I am reporting this.
DTAP and Comvax given 9/17/01. Rash appeared on legs, arms and face on 9/23/01. Tylenol was given. Brought to office on 9/24/01 with pink, flat macules, wheal and target shaped lesions on both legs and arms; 2-3 also on face. Spoke with Infectious Disease Expert and the impression was erythema multiforme secondary to Comvax. Rx'd Tylenol and to keep a close watch. Expected to be fine.
pt recvd vax 14DEC w/in 4 hrs devel swelling @ inject site & redness w/heat; by later evening swelling size of grapefruit; swelling dec in AM 15SEP redness still present extending to below elbow cont bend elbow; Cipro for infect
Crazy metal taste in my mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Crazy metal taste in my mouth) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (Crazy metal taste in my mouth). At the time of the report, DYSGEUSIA (Crazy metal taste in my mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information includes antibiotic (Unspecified antibiotic)Treatment information includes Ibuprofen
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm, vaccine administered at inappropriate site and accidental underdose. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the vaccine administered at inappropriate site and accidental underdose were unknown.  It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported however; it could be 64 or 65 years old. The patient received vaccine higher on her arm, which led to vaccine administered at inappropriate site. The patient had pain for 2 days and was now concerned whether she would get full benefit. The patient was also concerned that a few drops of vaccine were wasted prior to being given to her, which led to accidental underdose. Consent for follow-up was not asked. The reporter left chat during interaction.