chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gave Fluzone High-Dose to patient Under 65 year age / no AE; gave Fluzone High-Dose to patient Under 65 year age / no AE; Initial information received on 27-Sep-2019 regarding an unsolicited valid non-serious case received from a non-hcp (office staff).  This case involves unknown demographic (patient under 65 year age) patient who received  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and Expiry date unknown) via unknown route in unknown administration site.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.   At a time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
This spontaneous report was received from a medical assistant who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reactions or allergies was provided. On unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot# M014926 with expiration date: 17-FEB-2019 and lot# M025192 with expiration date: 21-MAR-2019 (dose and route of administration were not reported) as prophylaxis. The sterile diluent (manufacturer unknown) used was stored properly (lot# and expiration date not reported). The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 3 hours and 18 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006289: US-009507513-1707USA009050: US-009507513-1707USA009052: US-009507513-1707USA009053: US-009507513-1707USA009054: US-009507513-1707USA009055: US-009507513-1707USA009056: US-009507513-1707USA009057.
pt recvd vax; exp hives on inject arm; exp scratchy throat; tx dph
Three weeks after the second dose,  chest pain and low grade fever occurred. I had a similar episode before following a quadrivalent flu shot.  A month after the second dose, extreme hair loss started and within two months it progressed to Alopecia Universalis. I saw rheumatologist and dermatologist. Steroid injections and oral treatments did not stop complete  hair loss on head, eyebrows, and arms..
This spontaneous retrospective pregnancy report as received from a 22 year old female consumer with no Pertinent Medical History and no Drug Reactions/Allergies refers to her son. On an unknown date in October 2007 the son was received a dose of GARDASIL, injection, (lot #, expiration, dose and route unspecified), transplacentally. No concomitant medication was provided. Sometime in October 2007, since receiving GARDASIL, the mother stated that she had developed many "medical issues," including "liver disease, allergies, irritable bowel syndrome and a hiatal hernia." The mother stated that her son (who was conceived when the mother received GARDASIL) had developed autism and was legally blind. No demographics were provided for the son. The reporter stated that her son had also developed "a sleep disorder, a developmental coordination disorder, attention deficit hyperactivity disorder (ADHD), an orthopedic disorder and a mixed disorder of conduct and emotions. The outcome of son's event was unknown. Upon internal review, the event of legally blind was considered as medically significant. This is one of several reports received from same source. Additional information has been requested.
neck pain for the past 3 days and wont go away; felt febrile; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FA9899, expiration date: Mar2021), via an unspecified route of administration (given in the left side of her upper arm) on 19Dec2020 at single dose for COVID-19 immunization. The relevant medical history included diabetic from an unspecified date and ongoing, and allergic to NSAIDS. Concomitant medications included another unknown medication but the patient didn't know the name of the medication. The patient previously took metformin for diabetic (take metformin when it is high. when it is under control she does not take metformin); took motrin and experienced allergies (she says Motrin or well any NSAIDS make her tummy irritated when she takes them). The patient previously received flu vaccine for immunization and experienced fever. The patient received the vaccine at her hospital, took it last Saturday morning on 19Dec2020. She didn't feel anything after, she was fine. The next day she reported she was feeling pain in her neck on the side she got the shot. She took Tylenol for the pain. This had gone on for 3 days and it was not going down. She was wondering what to do about this, should she go to the emergency room or what should she do. The patient reported she had taken pain and muscle relaxer. She felt febrile, that was also why she took the Tylenol. The fever went down after taking the medication. Her fever was 99.8 but that was high as she was usually 97.0. This started Sunday, and she took the liquid Tylenol and it brought it down to 98.2. After that she was ok and only needed to take the one dose. She reported that she took another unknown medication but she didn't know the name of the medication. The medications she took, the pain medication and muscle relaxers helped a little bit but as soon as they wear off the pain was back and so bad. The shot was given in the left side of her upper arm. The neck pain started on 20Dec2020 and was ongoing and seemed worse. She thought the pain medication and muscle relaxer should be helping. She knew that this was a side effect so she wasn't worried when she started feeling the neck pain but it was taking too long, it should have been gone by the time of the report. She had had a fever after the flu vaccine and therefore she was not worried about having a fever with this vaccine. She had to take medication just once and then she felt ok. She hadn't taken the flu this year because she wanted to get the COVID vaccine. She has had no vaccines this year. The outcome of the event neck pain was not recovered, while the event felt febrile was recovered.
Suspected cellulitis at the site of injection, developed this 9 days post vaccination- redness, warmth, mild induration. No pain, no itching
Started developing morbiliform exanthem that spread to the whole body, sparing palms and soles of feet 4 days after Vaccination, Worsened into day 8 in spite of Prednisone 20mg Daily  2 doses. Also developed Temp up to 102 day 7-8.
On 03/17/2022 I was out of state and I started to get a cough and congestion. The following day I decided to take a rapid test and it came back positive. On 03/30/2022 I got back home and was treating the symptoms with Alka-Seltzer and Mucinex. I contacted my Primary Care Physician and had a PCR test on 04/01/2022 results came back positive. I was prescribed azithromycin. I also continued to take the Mucinex and Alka-Seltzer. The medication has helped and I feel at 95% now.
Flu shot injection into left upper arm felt different than previous years; felt an unusual fluid flow. The following morning I experienced the usual soreness but as the day progressed soreness became pain and I also noticed limited motion of my left arm. I increased activity to keep shoulder and arm moving. I used ice packs and a heating pad alternately as well as taking Tylenol hoping for pain relief.  Pain worsen at night and made turning over very difficult.  Hurts worse when used under pressure such as lifting or supporting weight. My left arm hurts when it lifted level to shoulders and when rotated from side to side. Arm is not the normal soreness as experienced with flu shots in the past. The pain does not seem to be going away.
complained of feeling faint, only had tea with sugar for breakfast   Cleared by NP after symptoms resolved
Headaches, sore throat, body aches, fatigue, nausea, mucus in nose
Information has been received from a physician concerning that his wife, also a physician, had a female patient who "sometime last week" was vaccinated with a dose of PNEUMOVAX 23 (lot # not available). "Right after the vaccination", the patient had a bad rash. The patient visited the physician for medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Severe hives all over trunk: back, chest, abdomen, neck, groin. Phone call to after hours MD. Monitoring for respiratory distress to take to er
Red, bumpy rash at injection site with mild itching twice total during day 1 and 2 of adverse event. Approx. 3 x 2 inches. Faded away gradually within 5 days.
At 03:00 AM the next morning after the vaccine, 09/22/2021- excruciating pain, it felt like somebody had put hot liquid molten and they were poking me mostly in my lower back. And then the headaches started and it was really bad. Then I got fever and chills, and my stomach was bothering me, I had nausea and diarrhea. The injection site on my left arm swelled up really big, I still have a knot size, the size of a golf ball that has not gone away. The pain is still there. The  pain in my arm, muscle pains, headache and chills have not resolved as of today, 09/29/2021. I had a telehealth,  09/27/2021, with the  Clinic and they told me to take Benadryl and wait it out.
ADMINISTRATION OF EXPIRED VACCINE TO ONE PATIENT; LEFT LONGER THAN 2 HOURS OUTSIDE THE FRIDGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-JUN-2021, the subject experienced administration of expired vaccine to one subject. On 01-JUN-2021, the subject experienced left longer than 2 hours outside the fridge. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine to one patient and left longer than 2 hours outside the fridge was not reported. This report was non-serious.
High Fever, Muscle Aches, Joint pain, Headache, Vision impaired, Vertigo, Muscle weakness, extremely loud ringing of ears, sores in mouth, lack of appetite, 3 lb weight loss, diarrhea. Unclear thoughts, extremely  vivid nightmares. lasted 4 days
ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND) 12/18/2022 BILAT GLAUCOMA SUSPECT ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/18/2022 BILAT GLAUCOMA SUSPECT HYPOXIA 1/3/2023 BILAT GLAUCOMA SUSPECT
Patient was given the pediatric formulation (PEDS) of the Pfizer COVOD vaccine. This vaccine is supposed to be diluted with 1.3 ml normal saline but the vaccine was accidently given without diluting first in the usual 0.2ml volume dose.  This delivered a dose of approximately 2.85 times the recommended dose to the patient, similar to the dose of the formulation for patients age 12 and over. At the time this was discovered and the patient's mother was contacted within a few hours of administration of the dose, she was not showing any symptoms.
Pt recvd DTP/OPV/HIB 11JUN91 had unconsolable screaming all day;
No additional AE; 2-month-old patient received VARIVAX in error; This spontaneous report was received from a physician assistant concerning a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 12-OCT-2023, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot number X006983 with expiration date internally validated as 07-MAR-2025 for prophylaxis (anatomical location and route of administration were not reported) (product administered to patient of inappropriate age). No adverse events reported.  At the reporting time, the patient's outcome was unknown.
LOSING SLEEP; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced losing sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from losing sleep. This report was non-serious.
DAY ONE after vaccine: 11:15 am Racing heart, rate between 110-125 as measured by patient's fitness watch,  chest tightness   went to ER,  was feeling more ill and was told it would be 4 hours until test results, patient left ER 8:30 pm  Temperature 102.9,  chills, patient took Tylenol every 4 hours, awoken from sleep with chills and tool Tylenol each time DAY TWO:  Chest tightness, fever, swelling/hardness/redness at injection site DAY THREE:  Chest tightness, vomiting from 3:30 am-9:30 am,  fever, swelling/hardness/redness at injection site, still feeling unwell
My symptoms started but I thought it was the flu, on 12/14. I woke up feeling feverish, lightheaded, sore throat, bad cough, runny nose. I normally have a chronic dry cough but told the PA that this was a different cough, I was coughing up phlegm. I just stayed in bed. I don't remember taking any medicine, but if I did it was probably acetaminophen. I took my temperature a few times but it was never over 100 on my forehead, but I was too hot so I took temperature in my mouth and it was over 100. I went to urgent care on Friday morning and spoke with PA, they tested me for COVID-19 and I was positive. She prescribed PAXLOVID and a cough medicine. I followed the instructions to the letter. Stayed in a room upstairs for five days, had a separate bathroom, tried not to cross contaminate anything. I got the medicine late Friday, so I started Saturday morning and almost immediately started feeling better.
COVID -19 vaccine given after BUD date of 4/29/22.   Expiration date: 5/31/22.   Letter being sent to parents to re-vaccinate patient.
foggy headed; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 13:45 (Lot number: EP6955) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRI-LO-SPRINTEC; FISH OIL; MULTIVITAMIN (16). Vaccination history included: Bnt162b2 (product=COVID19, lot number=EL3247, administration time=13:45, vaccine Location=Left arm,, dose number=1), administration date: 11Mar2021, when the patient was 37 years old, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 02Apr2021 07:00, outcome "recovered" (Apr2021), described as "foggy headed"; FATIGUE (non-serious) with onset 02Apr2021 07:00, outcome "recovered" (Apr2021), described as "tired". Therapeutic measures were not taken as a result of feeling abnormal, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
8 x 10 cm area of erythema, heat, tenderness, swelling several hours after vaccine given in right thigh.
Intermittent Rash started about 2.5 days after first pfizer covid vaccine. Rash would appear for about an hour, then disappear completely. About a hour later it would reappear in a different location on the body. This repeated itself for about 3 days. PCP office was contacted on 12/30, pictures were sent for them to review. PCP advised Zyrtek 5-10 ml per day until rash was gone. Patient had itching and seemed fatigued.
Patient was seen in ER. C/o pain in right arm. On 10-28-15 she didn't recognize her neighbor. Has prior history of leukemia Also c/o weakness and malaise.
My son experienced hallucinations several hours after 2nd dose. He also experienced really bad headaches that required more than one dosage of Tylenol. Slept for 10hrs after last dose.
08/09/02, A doctor contacted the nurse manger concerning the reaction the patient had from immunizations given 08/06/2002. He stated there was swelling all the way to the scapula on left side down to the left elbow he was concerned the child was developing cellulitis and started him on antibiotic. He stated that this was the second child he had seen with this reaction this week. He was concerned about seeing so many reactions this close together VAERS filed. Contacted Immunization Coordinator who is checking with state to see if there is any correlations to DTaP lot number.
(Sx's) urticaria; flushed; eyes bloodshot; rash - trunk; itchy scalp; 'thick' tongue (all within minutes after vaccines). (Rx) O2 sat. 99%; P 120; epinephrine 0.2 mg (sq) BENADRYL 6 cc PO; observed x 1 hour.
The pt cannot walk properly; she is very unsteady on her feet. While on prednisolone, does make progress. If dose is reduced, walking gets worse or she stops walking. She got very insecure and frightened and scared.  Diagnosed with transverse myelitis.
Temperature, 100.6; Aching all over; Severe headache; This is a spontaneous report from a contactable consumer (patient). A 72-years-old (73-year-old as reported) female patient  received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection,  Lot Number: EW0158, Expiration date not reported), via an unspecified route of administration, administered in left arm on 12Apr2021 at 11:30 (at the age of 72 years) as dose 1 single for covid-19 immunization. Medical history included Covid positive  (sars-cov-2 test positive on 04Jan2021) and she went to the emergency room, patient stated that she had to wait 90 days to get her vaccine. The patient's concomitant medications were not reported. Family Medical History Relevant to events reported as no. No history of all previous immunization with the pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) and no additional vaccines administered on same date of the pfizer suspect no. Patient did not receive any vaccine within 4 weeks, prior vaccinations. On 12Apr2021, the patient experienced severe headache at 5 PM (5 hrs 30 min after the vaccination) and aching all over at 10 PM (10 hrs 30 min after the vaccination). On 13Apr2021 (1 day after vaccination), patient had temperature 100.6.  The patient underwent lab test included body temperature: 100.6 on13Apr2021. The outcome of all the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Patient developed chest pain approximately 3 days after second Pfizer COVID vaccine. Patient went to the ER and was admitted with acute myocarditis and elevated troponins.
Crying non-stop since approximately 1 hour post injection (approximately 5:00 PM on 12/18/13) until ALTE at 4:00 AM on 12/19/13 (received the 5-in-1 immunization as well as flu immunization and oral rotavirus vaccine) in pediatrician's office. She had began to run a temperature (approximately 102) around 7:00 PM, was administered Tylenol for this. Around 9:00 PM, she vomited. She was given more Tylenol around 10:00 PM. She vomited around 4:00 AM on 12/19/13, then about 2 minutes later, went unresponsive, cyanotic around her lips, and apneic. CPR was performed for approximately 3-4 cycles by mother (who is a nurse) and EMS was dispatched. After about 4 cycles, she began moaning and having agonal breaths, which within 30 seconds became vigorous cries. She never had any seizure-like activity. She was admitted to Hospital for 2 days observation and discharged with the diagnosis of ALTE.
~12h after vaccine administration, severe body aches, fever, fatigue, malaise, nausea and vomiting lasting ~18h.
A report has been received from a Pharmacist concerning an 8 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The reporter stated that the patient had received entire dose in one nostril which started on 16-Oct-2013. The outcome of the event of received entire dose in one nostril is unknown. The report was considered to be non-serious.
Severe pain at injection site started 11 days after vaccination. Pain is constant even if not moving arm.  Minor pain after injection lasted about 2 days.
Arm swelled up; Inflamed, enlarged; Arm swelled up and it hurt; Really bad reaction; Got ill; On the floor for two hours/fell in the bathroom; Couldn't get up; Felt weak , knocked her out; Hit her head on the shower; This spontaneous case was reported by a consumer and describes the occurrence of FALL (On the floor for two hours/fell in the bathroom), DYSSTASIA (Couldn't get up), ASTHENIA (Felt weak , knocked her out), HEAD INJURY (Hit her head on the shower) and PERIPHERAL SWELLING (Arm swelled up) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004FZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Johnson & Johnson Covid-19 Vaccine on 06-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson Covid-19 Vaccine.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced FALL (On the floor for two hours/fell in the bathroom), DYSSTASIA (Couldn't get up), ASTHENIA (Felt weak , knocked her out) and HEAD INJURY (Hit her head on the shower). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm swelled up), INFLAMMATION (Inflamed, enlarged), PAIN IN EXTREMITY (Arm swelled up and it hurt), VACCINATION COMPLICATION (Really bad reaction) and ILLNESS (Got ill). At the time of the report, FALL (On the floor for two hours/fell in the bathroom), DYSSTASIA (Couldn't get up), ASTHENIA (Felt weak , knocked her out), HEAD INJURY (Hit her head on the shower), PERIPHERAL SWELLING (Arm swelled up), INFLAMMATION (Inflamed, enlarged), PAIN IN EXTREMITY (Arm swelled up and it hurt), VACCINATION COMPLICATION (Really bad reaction) and ILLNESS (Got ill) outcome was unknown.            The patient states she has other underlying health conditions.  No concomitant medications were provided.   No treatment medications were provided.
Employee received flu vaccine at 10 AM. He states he developed a scratchy throat and after lunch, later in the day, he developed shortness of breath, fever and a headache. Relieved with NYQUIL. The following day he developed a blister over the injection site.