chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was retrieved via a search of scientific literature on 14 November 2011. This reporter also reported other adverse events, which were captured in case numbers 2011-11217, 2011-11218, 2011-11219, 2011-11220, 2011-11221, 2011-11222, 2011-11223, 2011-11224, 2011-11225, 2011-11226, 2011-11227, 2011-11228, 2011-11229, 2011-11230, 2011-11231, 2011-11232, and 2011-11234. Verbatim from the abstract: "Background: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Methods: Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. Results: CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through other searches. Causality assessment using the modified agency criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. Conclusions: The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations". A 54-year-old patient (sex not reported) received an injection (route and site not reported) of INFLUENZA VACCINE, manufacturer and lot number not reported, on an unknown date. The patient had a history of elevated cholesterol, hypertension, and shrimp allergy. On an unknown date the patient developed facial diplegia 7 days after the vaccines. The causality was reported as possible. The outcome was not reported. Documents held by sender: None.
Patient walked to lobby after shot and passed out, then body shook. She was helped back to exam room and observed. She hit back of head and no bump forward. Iced area for 30 minutes. She left in 45 minutes in good condition. Ct scan normal next day.
PT RECEIVED GARDISIL(LOT 0548X EXP. 11/29/2010 MERCK) 0.5 ML IM RIGHT DELTOID WITHOUT DIFFICULTY. AS PATIENT WAS CHECKING OUT SHE FAINTED AND FELL AND WAS DESCRIBED AS HAVING SEIZURE SYMPTOMS(ARMS STIFF, EYES ROLLED IN BACK OF HEAD).  BP 110/80, BS 89, PULSE 49-50 AND IMPROVED TO 70 BPM WITHIN MINUTES, PULSOX 98%.  EMS WAS CALLED AND PT WAS TRANSPORTED TO THE HOSPITAL.
Patient states at 9:00AM 8/13/2021 dry, scratchy cough all day with shortness of breath and difficulty breathing.  Throat was swollen which was physically visible and noticeable with touch Saturday.  Swelling was the same as of 8/16/2021 4:10pm.  Patient also had diarrhea Saturday-Monday. Patient went to the ER, was prescribed Prednisone 20mg, 40mg daily for 5 days that was started 8/16/2021.
Very, very sore muscles, could not get out of bed, had to cancel Golf outing.
On 04/23/2021 I had a Rash on face, throat, and arm, more so on left side of body occurred within 6 minutes of injection (approx. 10:06am) - throat started to restrict shortly thereafter along with bumps on back of tongue, and hives on face.   Took one half of Benadryl around 10:20am which appeared to help rash a little so waited in hospital parking lot to see if any improvement but then took the other half around 11:30am and checked into the Emergency Room approximately at 12:00pm.   The doctor administered prednisone around 1:00pm via IV.  Then went home around 1:30-2:00pm.   Then at approx. 7:00pm another reaction - same thing (rash, hives, bumps on tongue, difficulty breathing), took one Benadryl.  Felt okay by 9:00pm.  Went to bed had a good sleep.  Woke up on 04/24/2021 and felt fine until 4:00pm and felt a reaction immediately , throat restriction, rash, hives, tongue bumps, difficult breathing - took two Benadryl and 6 prednisone.   Didn?t feel much improvement and returned to the ER which the doctors said to continue to monitor and follow a regimen of 6 prednisone a day the next day 5 next day 4, next day 3, etc until no reaction occurs.  So this is currently ongoing
pt recvd vax & exp inc severity in h/a & discomfort from shoulders & neck & jaw;
back pain after vaccine chest pain went to ER 6/1/2021 approx. nothing found diagnosed with muscle pull and now headache (believe it could be due to vaccine)
events are worsening; swelling of the left arm; sore left arm; "knot" the size of a fist at the injection site; itching; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling of the left arm), PAIN IN EXTREMITY (sore left arm), VACCINATION SITE MASS ("knot" the size of a fist at the injection site), PRURITUS (itching) and CONDITION AGGRAVATED (events are worsening) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A021A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy, Drug allergy, Allergy to antibiotic, Drug allergy (Eliquis (apixaban)) and Latex allergy.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PERIPHERAL SWELLING (swelling of the left arm), PAIN IN EXTREMITY (sore left arm), VACCINATION SITE MASS ("knot" the size of a fist at the injection site) and PRURITUS (itching). On 02-Mar-2021, the patient experienced CONDITION AGGRAVATED (events are worsening). At the time of the report, PERIPHERAL SWELLING (swelling of the left arm), PAIN IN EXTREMITY (sore left arm), VACCINATION SITE MASS ("knot" the size of a fist at the injection site), PRURITUS (itching) and CONDITION AGGRAVATED (events are worsening) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided. The action taken for mRNA-1273 was not applicable.
Initiall extreme exhaustion within about 2 hours. Fell asleep and could not be woken up for about 2 hours. Companion monitored me - respiration normal, pulse normal, mild low grade fever. Woke up on  my own after 2 hours and ate dinner. No loss in appetite or taste. Body cranky and restless. Slept  reasonably that night. A bit exhausted the following day. Slept well. All symptoms gone second day  following vaccine. Average arm soreness for vaccine.
Mother called and stated the (L) upper arm was swollen approx quarter in size, was red, and hard/hot to touch. Advised mother to draw a circle around the affected area and to call back in the am if the redness/swelling was larger. Also advised to apply cold packs for 24 hrs then to switch to heat packs.
Prior to the COVID-19 vaccines, Pt was a pillar in her community. Always the best dressed, soft spoken, very soft tempered, a newly retired tax collector, retired business owner, private person. A few days after the COVID-19 vaccine Pt started to act abnormal and has increasing gotten worse. She is in a constant state of euphoria, is speaking very rapidly, swearing, easy to anger, having issues sleeping (both falling asleep and staying asleep), not adhering to "normal behavior", i.e., going on the porch at 3AM to play music, talking freely to strangers about personal information, knocking on neighbors doors to talk or show new haircut, dressing in old or dirty clothes. Not appropriately acting to certain situations. Is however,  aware of this new behavior but does not  understand the impact that she is having on others by this.
body aches; felt shocking in feet; fast heart rate; blurry vision; rash; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), LIMB DISCOMFORT (felt shocking in feet), HEART RATE INCREASED (fast heart rate), VISION BLURRED (blurry vision) and RASH (rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), LIMB DISCOMFORT (felt shocking in feet), HEART RATE INCREASED (fast heart rate), VISION BLURRED (blurry vision), RASH (rash) and HEADACHE (headache). At the time of the report, PAIN (body aches), LIMB DISCOMFORT (felt shocking in feet), HEART RATE INCREASED (fast heart rate), VISION BLURRED (blurry vision), RASH (rash) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Numbness started in toes.  The numbness spread up to my knees, I was unable to lift my right leg, I had numbness in my hands and finger, loose of strength in all extremeties, lost all but one sensory perceptor, could not stand on my tip toes, heels, or do any toe to heel exercises, I had a drop foot, needed a cane to walk and I was very very tired.  I was diagnosed with chronic inflamatory demylinating polyneuropathy (CIDP).  I was sent to the hospital for the first IVIG treatment and have had 2 more since then. I am currently on a 6 month maintenance schedule because I still get numbness in my feet, loose strenth in my limbs, and walk with a cane.  This disease also affected my throid.  It is no longer stable and very hard to get to the point of being stable.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Little bit more of pain than what I had for the other two) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included VITAMIN D NOS and LORATADINE (CLARITINE) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Little bit more of pain than what I had for the other two). At the time of the report, PAIN (Little bit more of pain than what I had for the other two) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. Patient takes blood pressure medicine   This case was linked to MOD-2021-387844, MOD-2021-387845 (Patient Link).
Local reaction left thigh with induration and 6x9 cm area of erythema.  No fever or systemic symptoms.  Symptoms first noted the morning after immunization.
Hair loss; Hair loss was reported as worsened.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: EN6203) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, First Covid vaccine: 15Feb2021, Lot Number / Expiry Date: EN5319 , Route, Anatomical Location: left arm, No. of Previous Doses: NA), administration date: 15Feb2021, when the patient was 69 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "not recovered", described as "Hair loss"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "Hair loss was reported as worsened."  Additional information: Patient states her hair was falling out. She used to have a full head of hair, like a rug, and now her hair was thin, like a sheet of paper, or like a sheet on her bed. She was mad, as she used to have a full head of hair and it was now a crappy color and falling out. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s).
Elevated temp afternoon, night & the next day; light sz on 28NOV90 & then another one on the night of 29NOV90. Taken to hosp 30NOV90.
Patient had a pneumonia shot and the next morning had an infection. Very painful and swelling from my shoulder to elbow. Went to doctor. He hurriedly gave me a antibiotics prescription. My arm is better; still tender and I feel weak.
w/in 10 mins p/vax pt exp swelling, redness rt arm; given DPH 5ml PO;
My partner felt pain overnight. Then, felt flu like symptoms- plus chills- the next day and night. The following morning at 7:00 am, Patient said that she felt real sick. She also, complained of having a real bad Headache, Not long after that, she felt like throwing up. She tried to throw up. Except, nothing came out and she felt very nauseous because of the vaccine. When she came call to bed, I offered to make her some breakfast to help her feel better.  Unfortunately, she felt, too, I'll to try and eat an food because of the way she felt. So, I laid next to her with the hope that all would be well. Because, the pharmacist who administered the second dose.  Assured my partner, that it was normal to feel flu like symptoms the next day. So, we never doubted what the pharmacist advised. All of sudden, she suffered a cardiac arrest in my presence and died in front of me.
Fever of 101 degrees Tingling in left arm from shoulder to fingers Swollen lymph nodes under left arm Severe aching pain from left shoulder across chest and under the left arm Extreme fatigue Dizziness, light headedness Arm tenderness at injection site
side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
States that she developed "moderate fever" with associated generalized weakenss on day after HBV injection. States that s/s persisted x2 days and resolved by itself. Note she did not check temp with thermometer. Injection site "just itchy".
HEADACHE; UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a parent concerned a female of unspecified age. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and unspecified adverse event was not reported. This report was non-serious.
Pt called office at 1:59pm stating injection site was red and swollen. She said she started itching on her way home at injection site. C/O decreased ROM. Nurse advised cool compress, ibuprofen/ADVIL. 5/22/15 pt has redness down right arm, swelling and warmth. Pt states that arm feels better today than yesterday. Dr advised ibuprofen/ADVIL/MOTRIN, BENADRYL and ZYRTEC.
Get the shots. I have them now and they are tenable/Suspected Vaccination Failure; I have them now and they are tenable.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Get the shots. I have them now and they are tenable, Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have them now and they are tenable.). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she got the Shingle vaccine shots. The patient had them now and they were tenable. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Patient developed nausea, chills, lightheadedness/near-syncope, decreased appetite, weight loss, hoarse voice, a "nasty taste and smell", and worsened insomnia, anxiety, and fatigue after the 1st Moderna shot. Continues to have symptoms as of 4/5/2021.
Breakthrough covid case. Patient tested positive on 5/28/22 with an Abbott ID Now covid test at the Hospital. Presented to ER with c/o of fever, cough, runny nose, myalgia x 2 days. Recent travel. Patient had full Pfizer series on 1/7/21, 1/25/21 and the Pfizer booster on 10/5/21. Prescribed Paxlovid. Discharged home.
PT C/O OF ITCHY RASH TO LEFT ARM, LEGS AND LEFT SIDE OF WAIST SINCE RECEIVING FLU AND  PNEUMOCOCCIAL VACCINE 1/21/09. REFERS NOT USING ANY OTC MEDICATION TO TREAT RASH.
The day after receiving the SHINGRIX vaccine, I woke up with a severe headache, muscle ache, and chills. These symptoms lasted about six hours and then rapidly disappeared.
Pt states the left arm developed an egg at injection site. By morning painful to move the arm, redness increased, swollen, hot to touch. Pt had ice. Pt given antibiotic which she stared today with improvement. Pt states one thing, chart unclear whether reaction was to flu or pneumo.
It is now 6 days later and my breasts are swollen and sore. My nipples are red and also painful. In my left axillary area I have a sore tender spot also.
Just a few days after the first vaccine, patient began to feel funny so he checked on his portable Kardia devise that checks for A-Fib and he was in fact, going in and out of A-Fib.  He made an appointment with Dr. to discuss this.
20 min after 3rd vaccine, pt developed itchy, watery eyes right with erythema.  Slightly relieved with IM Benadryl lasting 3-4 days.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 10-MAY-2017, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB injection, lot # M046373 with expiration date: 04-NOV-2018 (dose, route and site of administration were not reported). The vaccine was stored in a nurse's unmonitored refrigerator and was exposed to temperature excursions of 47 to 77 degrees Fahrenheit for 46 hours and 32 to 35 degrees Fahrenheit for 46 hours. There were no previous temperature excursions and digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved in this case. This is one of five reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA011219: US-009507513-1705USA011218: US-009507513-1705USA011216: US-009507513-1705USA007715:
Woke up approximately 12 hrs after injection, shaking with chills and nausea. Spent entire next day in bed with body aches, warm flushes, lightheadedness and nausea.  Now feel better on the 5th with sore arm , but entire torso has reddened as if our in the sun. It?s not itchy.
Patient is a 66-year-old female with a history of COPD, sarcoidosis, previous bouts of pneumonia, coronary disease, hypertension and diabetes.  She presents to the emergency room in the company of her daughter complaining of worsening cough and shortness of breath.  Patient began having a cough 10 days ago which has gradually become worse.  She did a teleconference with her primary care physician yesterday who ordered an outpatient Covid swab.  Patient presents to the emergency room today complaining of increasing shortness of breath.  The daughter checked her oxygen level at home and it was 88% on room air.  Patient has not been using her inhalers like she should.
Onset 1 day after immunization. States that 5min felt itchy and when she scratches it leaves a "red patch." Pt has asthma but has noticed no increase in symptoms. Denies SOB. Pt. is diabetic.
From initial information received on 09/27/2004 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a female patient, age unknown, received her 5th dose of Daptacel vaccine, lot number C1700AA, as well as an IPV vaccination, an Act Hib vaccination, a Prevnar vaccination (manufacturer unknown) and a MMR vaccination (manufacturer unknown) on 09/22/04. Information regarding the lot numbers, site and route of administration for the administered products were not provided. Within 24 hours this patinet developed a large  red blotch and an area that was warm to the touch around the injection siet, exat site not specified. Reportedly, the patient recovered from this experience.  The reporter of this case is the same reportere of cases 200403223, 200403225, and 200403226.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: taken to ER by paramedics, treated with 3-4 more doses of epi. discharged several hours later
A few days after the booster I started feeling anxious, tired, and with flu-like symptoms including deep cold body aches, headaches, burning sensation, numbness and tingling in different parts of the body, and pins and needles . Also, ringing in the ears (tinnitus) and difficulty sleeping. One night (1/29/22) woke up feeling like I couldn?t breathe and ended up in the ER.
started achy in shoulders, chest and back - worsened chills, elevated temp of 100.3 (ear thermometer) tired and slept slept til 9:30 am next morning  - felt normal upon waking
Started with Fatigue, Then joint pain  in body. Last night has very intense toe pain left two toes. Felt Hot, didn't check temp as was in bed. Some  Shortness of breath with mild exertion.   Awoke with feet hurting. Possibly sense of taste was affected.