chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tinnitus/noise in their heads; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus/noise in their heads) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus/noise in their heads). At the time of the report, TINNITUS (tinnitus/noise in their heads) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment Information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-150248 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-150248:
My mom became very disoriented for 2-3 full days.  She couldn't remember her birthday, where she was, her doctor's name, etc....  We took her to her doctor and she thought she had a stroke.  We went to the ER for every test possible.  She became disoriented and also had to put adult briefs on her.  On Sunday she was driving and on Monday she was totally disoriented.  My dad called and I rushed home 2 1/2 hours away.  This was a terrifying event.   She was glossy eyed and couldn't read.  She didn't have any paralysis; thank goodness.  It was all pretty much mental.
Post vax, the pt developed URI symptoms. Was seen in office on 9/14/00 with nasal congestion. She had a cardiac event on 9/16/00 and died. Autopsy revealed SIDS. Autopsy shows pulmonary edema.
she had a significant amount of swelling and large rash around site of injection 8 days after shot on 12/28. She called the vaccine line and they instructed her to follow up with her PCP. She went to see her PCP and they gave her a steroid cream to help reduce swelling and told her to take Benadryl as needed. She stated the swelling and redness have gone down significantly, but still has slight swelling and it is now a slight pink color.
Patient states started feeling light headed and week about 5 minutes after COVID injection. No rash, difficulty breathing. An IV of 0.9% sodium chloride was started. Patient received 25mg of diphenhydramine IVP and 125mg of methylprednisolone IVP . Patient discharged to home without incident.
pt recv vax 15NOV94 & 18NOV95 had enlarged lymph nodes noted on lt side & swollen axilla glands;lymphadenopathy;dx stage III small cleaved cell, disseminated lymphoma, nodular type;sx diarrhea & sl nausea & vomiting, h/a, temp elevation
1/26 and 1/27 left arm pain  all day  took Alleve  1/28/21 at 630 am had red  rash at injection site not itchy , slight pain at the touch
3/26/07 Dtap, IPV et MMRV given. Ran fever per mother day of vaccine. No fever since. Rash started on hands and spread to rest of body by 3/29/07, TX: Benadryl 12.5mg/5ml Elixir 3/4 tsp Q 4.6 hrs and Prelone 5mg/5ml. Syrup 1 tsp BID x 2 days 1 tsp x 2 days 1/2 tsp x 2 days.
This spontaneous case from a consumer was received from a Consumer Company (Mfr.control no: US0JNJFOC-20140916023) along with additional information received from another Agency on 16-Sep-2014 and was forwarded to another Agency on 11-Oct-2014. This case involves an off label use for population (72-year-old) for ZYRTEC Children's Dissolve Tabs 10 mg Citrus as per the local labeling. The patient initiated treatment with cetirizine hydrochloride dissolve tablet (batch no: 42602815 and expiry date: Nov-2016) orally at a dose of 10 mg daily for seasonal allergies. Non-company suspect drug included "Flu shot" (Flu vaccine (influenza vaccine)). The patient had been feeling out of it. She reported that she had flu shot "last week (Sept-2014)" and had a sore throat since then. At the time of this report, it was unknown if the patient continued treatment with cetirizine hydrochloride and influenza vaccine. The outcome of the events feeling out of it and sore throat was unknown. The reporter assessed the events as related to cetirizine hydrochloride. Consumer report: A 72-year-old patient on cetirizine hydrochloride Children's Dissolve Tabs (off label use for population as per the local labeling) experienced the events after an unknown period of initiation of treatment. Co suspect medication included influenza vaccine. It was unknown if the patient continued treatment with cetirizine hydrochloride and influenza vaccine. the outcome of the events was unknown. The reporter assessed the events as related to cetirizine hydrochloride. The Case Company Causality is determined as Related.
Received call from mom. Child crying uncontrollably for 2 hours. Unable to sooth child.
dizziness, lightheadiness, flushing, sweating, anxious, offered juice, observation done, symptoms resolved, pt went home
arm became super red; hard; hot; itchy; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (arm became super red), VACCINATION SITE INDURATION (hard), VACCINATION SITE WARMTH (hot) and VACCINATION SITE PRURITUS (itchy) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for an unknown indication.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm became super red), VACCINATION SITE INDURATION (hard), VACCINATION SITE WARMTH (hot) and VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE ERYTHEMA (arm became super red), VACCINATION SITE INDURATION (hard), VACCINATION SITE WARMTH (hot) and VACCINATION SITE PRURITUS (itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter..
pinky looking arm at the injection site; itching; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (pinky looking arm at the injection site), PRURITUS (itching) and OROPHARYNGEAL PAIN (sore throat) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN, HYDROCHLOROTHIAZIDE, PRAVASTATIN, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), PAROXETINE and RESTIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE;THIAMINE;VALERIANA OFFICINALIS] for an unknown indication.    On 05-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 VACCINATION SITE DISCOLOURATION (pinky looking arm at the injection site), PRURITUS (itching) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, VACCINATION SITE DISCOLOURATION (pinky looking arm at the injection site), PRURITUS (itching) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was given antihistamine in response to events. Her symptoms were not relieved by the antihistamine.
Patient states arm feels numb, no sensation, doesn't feel touch, and itchyness/tingliness that radiates down to both hands.
Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer (works as a non-emergency medical transporter). A 67-year-old female patient started to receive bnt162b2 (BNT162B2 reported as Covid-19 vaccine; lot number: EL1284; expiration date: unknown), via an unspecified route of administration left arm on 31Dec2020 at a single dose for covid-19 vaccination. The patient has no medical history. The patient's concomitant medications were not reported. The patient reported that she had the Covid-19 vaccine last Thursday (31Dec2020). She was asking if nausea, vomiting and diarrhea were side effects since she has experienced these. The outcome of the event vomiting was recovered on 07Jan2021 with sequelae while the outcome of the other events was recovering.
?within a few weeks, bronchitis which went into bilateral pneumonia. Upon being admitted to hospital, it was discovered he had an acute exacerbation of pulmonary fibrosis. Previously, he was **completely** asymptomatic and incredibly active with yard work, walking, climbing stairs and ladders?no respiratory issues, whatsoever.  He was in hospital four weeks before he deceased. The pneumonia had long cleared but the PF had not.
Muscle Aches; Joint Aches; Nerve Aches; Extreme Fatigue; Loss of Strength; Weight Loss; Lack of balance; Decreased physical activity; Sore Arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriasis and psoriatic arthritis. Concomitant products included dabigatran etexilate mesilate (Pradaxa).   On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 18th April 2019, the patient experienced muscle pain, joint pain, nerve pain, fatigue, strength loss of, weight loss, balance disorder and decreased activity. Shingrix was discontinued. On an unknown date, the outcome of the pain in arm and weight loss were recovered/resolved and the outcome of the muscle pain, joint pain, nerve pain, fatigue, strength loss of, balance disorder and decreased activity were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, muscle pain, joint pain, nerve pain, fatigue, strength loss of, weight loss, balance disorder and decreased activity to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient for himself. The patient had received the acupuncture treatment for psoriatic arthritis for approximately 5 years. The patient was able to walk his dog 5 times daily. On the same night, when the patient received Shingrix in the left arm, he complained of sore arm. One day after receiving Shingrix, the patient complained of aching muscles, joints and nerves in the body, also extreme fatigue and loss of strength resulting in lack of desire to get out of bed except to use bathroom and to eat but still experienced weight loss at the time of reporting. After vaccination, the patient could not walk his dog 1 block and it took 1.5 months to be able to walk 1/2 a mile. The patient mentioned it felt as if he had a heart attack due to lack of balance and decreased physical activity. The patient reported that he was feeling as if just getting better, but still not fully recovered at the time of report. The caller left feedback to update warning should be mentioned for psoriatic arthritis patients and even rheumatoid arthritis patients in general due to boost in immune response and these patients try to decrease immune-mediated responses. The patient would not receive 2nd dose. The reporter consented to follow up. This case had been linked with case US2019123865 reported by the same reporter for multiple patients and US2019123863, reported by the same reporter for his wife.
Pt was receiving Moderna dose 2. During the injection, the needle became disconnected from the syringe and an unknown amount of the vaccine squirted onto the patients arm. Reached out to CDC who recommended that due to being unable to asccertain how much of the vaccine the patient received, the patient should receive another dose to complete her series.
Hives; This is a spontaneous report from a contactable other healthcare professional from a Pfizer-sponsored program. A male patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date as single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hives on an unspecified date with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
PT RECEVED ANTHRAX #2 ON APRIL 1ST. PT SHOWED UP AT ER OON 3APRIL WITH A LOCAL REACTION BETWEEN SHOULDER AND ELBOW AND RECIEVED KEFLEX. ERYTHERMA & TTP TO RIGHT ARM FROM SHOULDER DISTAL TO HAND. ENTIRE ARM IS WARM WAS DIAGNOSISED ON 4APRIL AND WAS ADMITTED TO RECIEVED IV ANTIBIOTICS
I took out my contact lenses and my eyes became very itchy around 11:00PM. Around 10 minutes after initial itch, eyes and eyelids began to swell and turn red.  Eye balls were bloodshot and difficult to keep open. Redness appeared around the eye area. Placed a cold compress on infected eye area, kept eyes closed as much as possible and took a Benadryl. Went to bed. Next morning at 7:30AM  redness has decreased around the eye area. Eye lids are sore and eyes are still slightly bloodshot. I have refrained from inserting my contact lenses and am wearing by glasses.
This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, muscle pain, fever and chills. On an unknown date, the outcome of the influenza-like symptoms, muscle pain, fever and chills were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, muscle pain, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The patient experienced substantial flu like symptoms for 24 hours, muscle aches, fever and chills. The reporter agreed to be followed up. This case is linked with US2018GSK173205, reported by the same reporter.
p/vax pt presented w/a pink, itchy, raised rash located on rt upper thigh for 2 days;dx as herpes zoster w/a vesicular appearance;pt febrile & returned to MD office 6/23/98 d/t lesions becoming painful & spreading;
Left side chest pain that got progressively worse over the course of the week following vaccination. 6 days after vaccination, pain had become severe. 7 days after vaccination, pain began to dissipate.
Itching at injection site, hard, hot to touch, red the size of a dollar coin. No treatment.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/7/22. When error discovered facility contacted CDC for course of action. At direction of the CDC, patient contacted regarding occurrence to offer re-vaccination of dose. Patient accepted revaccination on 1/28/2022. No adverse side effects or event as result of dose.
About ten days after getting  the Covid vaccine, I developed odd sensations in my left arm and a red rash  on my palm, below the little finger. I then developed bouts of significant pain in the L. shoulder, along with stabbing; burning; itching; throbbing; tingling; aching ; numbness in my left arm/hand/fingers.   I saw three doctors, my primary care, an (privacy) medicine doctor, and finally got into a neurologist. I was diagnosed with neurologic amyotrophy/Parsonage-Turner syndrome.
Worsening breathing similar to asthma-like condition.  It started the day after the first vaccine and worsened after the second.  Requires use of albuteral inhaler on a PRN basis.
Severe sneezing; Severe mucus production; severe nasal congestion.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in left arm on 26Mar2021 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medication. No known allergies were reported by the patient. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced severe sneezing, severe mucus production and severe nasal congestion. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events severe sneezing, severe mucus production and severe nasal congestion were not recovered at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit intermittently for 120 days and also 15 to 46 degrees Fahrenheit for 1 hour. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected because no consent was given for further contact.; Sender's Comments: US-009507513-1703USA013715:
Patient said since vaccination she has experienced tingling in the arm where she received the flu shot. She said it happens daily and intermittently. She will follow up with her provider at the Medical Clinic immediately.
Welts (L) arm intradermal injection. Redness at injection on 4th day & "itching" then hives in groin Sun at emergency room approx 1 pm increase in hives. Rx with BENADRYL. 1 hr later had hives from shoulder to feet. Back at ER - tx steroid shot & oral with BENADRYL 4 x day, ALLEGRA 2 x day, XANAX BID. 20th before feeling better.
Increase of baseline temp of one degrees F 98.9 at 7:30 AM, 2cm raised, tender to touch, reddened area around injection site noticed while bathing. Unknown time of onset at injection site.
pt extremely fussy immed p/vax given; irritability progressed to 3 hr episode of screaming; lt leg red from hip to knee & edematous; mom alternated cold & warm compresses;
Pt recvd vax 21APR92 & on 4MAY92 devel swelling of the salivary glands; 5MAY92 felt ill devel a sore throat & was treated w/unspecified ATB; 6MAy92 devel a fever of 102; runny nose & cough; seen by MD who made the dx of mumps;
Patient developed rash/hives beginning 3-4 days following receiving both Shingrix & Boostrix but she also started taking gabapentin for the first time that day.
T104 w/in 24 hrs of DTP/HIB/OPV also vomiting;
Arm was sore a fee days; This case was reported by a consumer via interactive digital 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 Information: GSK Receipt Date: 02-Jun-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient got the first dose of the shingle shot. The patient had sore arm for few days. Additional Supportive: The follow-up would not possible as no contact details were available.
Day after second Pfizer shot, March 13, 2021, experienced prolonged heart palpitations and blood pressure of 175/110 and pulse over 130.   No history of hypertension.   Around mid-April started to experience heart palpitations again with high blood pressure readings accompanied by pressure in chest area.   Incidents do not occur every day but were cause for alarm since they are not typical.   Made appointment with doctor.   Physicians Assistant ordered 24 hour BP monitor.  Results of study - no hypertension.  Blood test was also ordered - results normal.   It was recommended that if spikes in BP and heart rate continue, contact doctor's office.
I felt a small amount of fatigue after the dose, so I took things slow for the first few days. Then four days after the dose I felt moderate light-headedness while out for a walk. It passed after an hour or two.  Four days after first dose, I woke up with extreme dizziness and vertigo that made it difficult to balance without placing a hand on the wall. The first dizziness passed, but over the next few days I felt feverish and had pressure in my left ear. These symptoms (fever, fatigue, dizziness, ear discomfort) continue to persist now 10 days after the first dose and show no sign of abating.
Patient reported lip swelling, facial swelling, shortness of breath, chest tightness approximately 30 minutes after administration of vaccine. Patient was given one dose of Epi-pen 0.3 mg intramuscular injection and sent to ED via ambulance for observation. Patient was seen in ED and discharged home after 6 hour observation (pt given another dose of Epi-pen,  steroids, Benadryl, Pepcid in the ED).
p/vax pt devel Bell's Palsy on rt side;pt still improving but weakness cont;
PATIENT REPORTED FEELING DIZZY, LIGHTHEADED, "ARMS FLOPPING" AND MY TARDIVE DYSKINESIA IS "ACTING UP"
Immediately after vaccination, nausea started on day 1 and continued till day 5 (current). Felt extreme fatigue (8 or 9 on a 10 scale) on Day 1, within 4 hours of vaccination Within 4-6 hours of vaccination, headache started (on and off).- took Ibuprofen 400 mg once on Day 1. Symptoms went away for few hours. On Day 2, completely lethargic, feverish-had to take ibuprofen 400 mg twice during the day. Nausea continued on day 2. Routine activities completely disturbed. On day 3, 4,5- overall improvement with symptoms but even if little physical activity-like standing for 15-20 minutes is painful-causing muscle cramps. on Day 4, menstrual cycle started 8 days before the expected date. Periods not heavy at the moment  Day 3,4,5- mental confusion- difficulty in processing information or think. Still able to continue work but with difficulty.