chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around 6 pm the same day of first pfizer vaccine (3/18/21), i woke up from a nap and my back hurt so bad that i couldn't leave the bed without falling out. My parents came and helped me out and gave me painkillers but really nothing helped. Next day, it started down my right arm (the arm NOT injected with the shot) and it started to hurt in my muscles everywhere and hasn't stopped to this day (3/25/21). Numbness and pins and needles feeling have occurred in my pinky and ring finger of right arm. Pain has now started in my knees as well after a few days from the shot. No pain killers work and I'm unable to write or type properly, or even work at my job frankly. I can't hold an object without it falling out of my hand, and when i am able to hold something, after about 2 seconds pain fills my arm. Nothing helps the pain. I saw my primary care physician on 3/25/21 and the PA said there wasn't anything to do for the intense pain i was having except take tylenol arthritis, melatonin (to help me sleep through the pain), exercise (even though it may cause me even worse pain), and a stress ball for my arm. I don't know what else to do with this pain and this was only the first round of shots.
About 2.5 hours after immunization client developed hives over arm, legs and trunk with itching. No other symptoms. Has taken flu shots "for years".
History Chief Complaint Patient presents with ? Cough     x yesterday, 100.4F ? Nasal Congestion     exposure to daughter 2 days ago      Patient is a 60 y.o. female    HPI   Patient presents urgent care this morning in order to be tested for Covid because she developed cough and cold symptoms yesterday, also exposure to someone with Covid 2 days ago.  Symptoms started gradually.  Mid to nasal congestion, rhinorrhea, cough.  Admits to low-grade fever at home.  Denies sore throat. Denies chest pain, trouble breathing, abdominal pain, n/v/d.  States that she was exposed to her daughter with Covid 2 days ago. ....
I have a lump that feels like a bruise but it is not discolored, there is no entry point (as if a bug bite) and its not hot (like an infection or bacteria i.e. MRSA) it's just a lump that is tender.
Rash to armpits, elbow clefts, abdomen and feet accompanied by a nosebleed.  Admitted to hospital for for Thrombocytopenia. He is receiving IVIG and IV steroids along with a platelet transfusion.
Shingles; Holes with blood spurting out; Pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (outbreak in December 2005), blister, nerve damage and pain in arm. Concomitant products included Herpes zoster (Shingrix).   On 10th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 17th July 2019, 7 days after receiving Shingrix, the patient experienced shingles, skin bleeding and pain. On an unknown date, the outcome of the shingles, skin bleeding and pain were unknown.   It was unknown if the reporter considered the shingles, skin bleeding and pain to be related to Shingrix.  Additional information received were as follows: The patient had shingles in December 2005 which occurred on the right upper arm (including under the arm), right shoulder, and back of right should (around scapula). The patient received Shingrix on left arm. The patient experienced shingles again on the right upper arm (and under the right upper arm), right shoulder, and right scapula area of the back. The patient reportsed that this outbreak was milder, and he had less pain than when he had the first outbreak. He also reported that with the first outbreak he had blisters. This time the patient had holes with blood spurting out. The patient reported that he had nerve damage and pain in his right arm since having the shingles in December 2005. The reporter gave permission for his physician to be contacted.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection (strength, dose, route of administration were not reported) (lot # N022728 expiry date: 31-MAY-2020) for prophylaxis. The vaccine was stored in 32 degrees Fahrenheit (F) up to 35 F (32.3 F) for 1 hour 45 minutes and 30.2 F for 37 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No further information was provided. There was no product quality complaint (PQC) reported. This is one of the three reports received from the same reporter. Sender's Comments: US-009507513-1804USA005778: US-009507513-1804USA005779.
10/06/2006 severe pain in right shoulder. 10/06/06 hospital ER. Given pain killer and told to see a physician. 10/09/2006 saw orthopedic Surgeon. Had W rays and MRI. 10/10/06 diagnosis deltoid hematoma from injection, acute rotator cuff tendonitis, septic arthritic from the injection. Given pain killer, antibiotics and rehab.
Localized erythema, minimal edema to left upper deltoid at injection site. No systemic symptoms. Afebrile.
Typical urticarial rash only (classical) Immediately following vaccinations rash developed after DTaP and IPV rapidly.
Information has been received from a physician via an unspecified reporter thought the company representative, concerning a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 25-NOV-2014, the patient was vaccinated with an unspecified improperly stored dose of RECOMBIVAX HB 10microgram/ 1ml "10x1 DS/VTF" (lot number J008227 with an expiration date of 07-FEB-2016) (route, dose and anatomical location were not reported). Other suspect and concomitant medications were not provided. No adverse effects were reported. The dose of the vaccine experienced a lowest temperature excursion of 28 Fahrenheit (F) for 72 hours, and a highest recorded temperature during the temperature excursion of 47 F for 40 hours. The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Unknown onset of adverse events.  PT received second COVID vaccine on 3/26/21.  She was found deceased in her residence (where she lives alone) by family on 3/28/21.  She was found in bed, appropriately covered with blankets.  Son last spoke with PT around 17:30 hours on 3/26 after receiving the vaccine, and reported the PT did not complain of any symptoms, did not sound short of breath, and did not complain of any breathing difficulty.  Based on postmortem presentation, believed PT died late night of 3/26/early morning of 3/27.  Suspect death is likely due to PT's heart disease, Medical Examiner agreed with the assessment.I spoke with the clinic that administered the second dose, and was informed that the PT did not exhibit any signs/symptoms during the observation period immediately following the vaccine being given.  PT's PCP was contacted, and agreed to certify DC based on known medical history.  PCP also agreed that the death did not sound related to the vaccine based on lack of symptoms as reported by the administering clinic and family.
About 5 pm same day as shot, muscle aches in neck and back, lasted through night, plus adding in hip aching and very tender injection site.  Next day some lower GI discomfort, slight headache and very tired.  Afternoon of this second day, became cold having trouble getting warm enough.  Even after short nap, continued very tired with continued aching muscles, although less after 8 pm
lump in rt thigh @ site of DTP/HIB on 20FEB97;no fever or systemic problems;on exam has 1x1cm firm, non tender, non inflamed mass;suspect hematoma or inflammation;use warm soaks;
Full blown flu symptoms; Headache; Fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Full blown flu symptoms), HEADACHE (Headache), PYREXIA (Fever) and NAUSEA (nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No medical history information was reported.     On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced INFLUENZA (Full blown flu symptoms), HEADACHE (Headache), PYREXIA (Fever) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-May-2021, INFLUENZA (Full blown flu symptoms), HEADACHE (Headache), PYREXIA (Fever) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medication include progesterone, estrogen, testosterone for menopause.  Within 20 minutes she experienced a headache, 10 minutes after that a fever. Temperature unknown. Within 1 hour, she experienced full blown flu symptoms and nausea.   Patient described symptoms as a cross between the worst hangover and flu. Patient is not actively experiencing any symptoms at the current time.
PATIENT WENT INTO SYNCOPE 5 MINUTES AFTER RECEIVING THE VACCINATION AND HAD SEIZURES. HE TURNED RED AND STARTED SWEATING . HE SAID HE HAD NUMBNESS IN HIS HANDS AND FEET AND THEN HE HAD A TINGLY SENSATION AND WAS FEELING WOOZY. THE PARAMEDICS WALKED HIM NEXT DOOR TO THE IMMEDIATE CARE AND THE ATTENDING DOCTOR CALLED AND ME AND INFORMED ME THE REACTION WAS VASOVAGAL AND WAS MOST LIKELY FROM ANXIETY.
HIGH BLOOD PRESSURE; CLAMMINESS; DILATED PUPILS; DELAYED RESPONSES TO STIMULATION; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 31-AUG-2021 for covid-19 prophylaxis. Non-company suspect drugs included: nirmatrelvir/ritonavir (oral, batch number: GK8531 expiry: UNKNOWN, form of admin was not reported) dose and frequency were not reported from 12-SEP-2023 to 13-SEP-2023 for covid-19 treatment. Concomitant medications included dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride.  On 2023, the patient experienced suspected covid-19 infection. On 12-SEP-2023, the patient experienced high blood pressure, clamminess, dilated pupils, and delayed responses to stimulation. Laboratory data included: Blood pressure High, and Heart rate High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from high blood pressure, clamminess, dilated pupils, and delayed responses to stimulation, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
No adverse event; Patient received the Moderna Covid-19 vaccine after use by Date 6-Apr-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after use by Date 6-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. as7180b) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after use by Date 6-Apr-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after use by Date 6-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after use by Date 6-Apr-2023).    No concomitant medications were provided. No other adverse events have been reported Date of administration of vaccine on 22-Apr-2023 (3 patients), 21-Apr-2023 (5 patients), 20-Apr-2023 (2 patients), 16-Apr-2023 (1 patient) and 12-Apr-2023 (1 patient). The patients involved were all over the age of 65.  No treatment medication was provided. This case contains information for the 5th of 12 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721060 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721060:Patient 1
received a dose of the vaccine more than 12 hs after first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine more than 12 hs after first puncture) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine more than 12 hs after first puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine more than 12 hs after first puncture) 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.   Concomitant medications was not provided by the reporter Treatment information was not provided
Patient here to receive her 1st Dose Pfizer Vaccine. Patient alert, and  oriented at time of vaccine. Received vaccine in Shot Room, stood up, stated she was OK, proceeded to Pediatric waiting area and sat in chair. Seconds later ~  12:45 PM, mother calling for some one as patient had fell out of chair onto floor face down. Mother and Nurse got her up and sat her in chair. Patient not responding, although she was breathing and had a pulse. Cool wet paper towel compress to forehead and face. Patient came to, but unaware of what had happened. Provider notified to come to area to assess patient. B/P- 97/61 P- 80, SPO2- 95%- 98%. Patient moved to an exam room, pale in color, shaking her head as her mom encouraged her to stay awake. Refusing an ambulance for care. Cool compresses to face, forehead and back of neck. ~ 12:54 patient alert and oriented, talking with mom, as color began to return. Drinking a cool Lemon Ice tea. Patient unaware of what happened. Does not recall falling to the floor. Patient did state that after the injection she felt dizzy, but did not say anything to Nurse or mother. ~ 1:00 PM- B/P- 100/74 P- 94 SPO2-96%. ~1:20 PM patient continues to complain that her nose hurts, cold ice pack applied to area, Provider aware of same. Parent encouraged to follow-up immediately with her Pediatrician to ensure that her nose is OK. Father arrived on the scene- ~ 1: 15 PM. Patient encouraged to stand and move around before leaving. ~ 1:35 PM family left the facility, again encouraged to follow up with Pediatrician.
Hives, rash on face, pain in right eye, pain in right side of head, mild sore throat, sinus pressure.
Starting around 7 hours after the shot, I started to fell fatigued. My head also felt foggy. I went to sleep at 11pm, and awoke about every 3 hours. At 5 am, a terrible migraine set it. I took 1000 mg Tylenol and laid in bed for about 45minutes until it kicked in. At this time I also had complete body aches, but nothing hurt worse than my arm. The I slept another 3-3.5 hours. In the morning, the headache was less intense, the fatigue was still there but not debilitating, and the brain fog was present but minimal. I had nausea hit 3-5 times, but usually subsided within 5-10 minutes. 24 hours after the shot, I started spotting, mostly dark, chunky bits of uterine lining. I am not scheduled to start my period for 12 days. The spotting has increased - I?m now on my second tampon before heading to bed. I?ve also developed a small rash about 1-2 inches below the injection site, which feels warm, and is red in a rough square shape about 2?x2?. I still have a faint headache.
Sensitivity in her arm; Headache in forehead and back of neck; Little bit of chilling; Stomach felt upset; Headache in forehead and back of neck; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Sensitivity in her arm), NECK PAIN (Headache in forehead and back of neck), FEELING COLD (Little bit of chilling), ABDOMINAL DISCOMFORT (Stomach felt upset) and HEADACHE (Headache in forehead and back of neck) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced LIMB DISCOMFORT (Sensitivity in her arm), NECK PAIN (Headache in forehead and back of neck), FEELING COLD (Little bit of chilling), ABDOMINAL DISCOMFORT (Stomach felt upset) and HEADACHE (Headache in forehead and back of neck). At the time of the report, LIMB DISCOMFORT (Sensitivity in her arm), NECK PAIN (Headache in forehead and back of neck), FEELING COLD (Little bit of chilling), ABDOMINAL DISCOMFORT (Stomach felt upset) and HEADACHE (Headache in forehead and back of neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.
11 P -> Fever to 104 requiring visit to Emergency Room for reassurance. Pt. was lethargic from fever. High dose TYLENOL alt. with MOTRIN.
Breakthrough COVID infection. Reports cough. Unsure of symptom onset. Tested for post discharge placement.
Stomach Issues; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach Issues) and DIARRHOEA (Diarrhea) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 ABDOMINAL DISCOMFORT (Stomach Issues) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL DISCOMFORT (Stomach Issues) and DIARRHOEA (Diarrhea) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the 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
Large, warm and tender indurated area at site of VARIVAX- 7x9cm.
Redness at injection site; warmth and redness at the injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE WARMTH (warmth and redness at the injection site) and PAIN IN EXTREMITY (Sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 006B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, the patient experienced PAIN IN EXTREMITY (Sore arm). On 12-Jan-2022, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE WARMTH (warmth and redness at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE WARMTH (warmth and redness at the injection site) had not resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
This case was reported by a physician and described an adult male pt did not respond immunization with hep B vaccine (manf unk). The pt's medical history, concurrent conditions, and concurrent medications were not reported. The physician reported that on unspecified dates several years ago, the pt received a series of injections of hep B vaccine (manf unk). The pt also received yearly boosters. It was subsequently determined that the pt never had a detectable titer. The physician stated that he did not know specifically when the titers were being drawn in relation to when the immunization series was completed or boosters were received.
Headache, Fever, Diarrhea, fatigue, chills, injection site pain Narrative:  Other Relevant History:
arm was useless for a week / pain in each arm; This case was reported by a consumer via media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The reporter mentioned that, he/she was not expected the amount of pain he/she experienced after getting each shot. The patient's arm was useless for a week. The reporter mentioned that, Shingles vaccine did not make him/her sick but he/she was not expected the pain in each arm, but he/she did not regret it at all. The reporter mentioned that, he/she would do it over a hundred times plus before getting shingles. The follow-up would not be possible, as no contact details were available. For the tolerability of 2nd dose, refer case US2021AMR122245 reported for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR122245:Same reporter
Initial misuse report received from a healthcare professional on 17 July 2013. A 12-year-old patient was administered DAPTACEL instead of ADACEL for TDAP vaccination. No adverse event was reported. List of documents held by sender: none.