chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient tested positive for COVID; Patient tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 22 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Apr2021 11:00 (Lot number: EP6955) at the age of 21 years as dose 2, single and intramuscular, administered in arm left, administration date 23Mar2021 11:00 (Lot number: EP6955) as dose 1, single for covid-19 immunization. The patient's relevant medical history was not reported. The patient's concomitant medications received within 2 weeks of vaccination was reported as unknown. It was unknown whether the patient was pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: VACCINATION FAILURE (medically significant) with onset 14Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 14Dec2021, outcome "recovering" and all described as "Patient tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Dec2021) positive. The reporter seriousness was reported as non-serious. Therapeutic measures were not taken as a result of covid-19.  Follow-up attempts are completed. No further information is expected.
Redness, some itching, red area began growing, increased from 1 x 2 inch to 3 x 6 inch; hot, swollen.
Nausea (threw up), chills (temp high 99.0), major headache, tired. Lasted until 10:00am on 4.5.211.
Lump to injection site. Redness to Left arm 8 cm x 12 cm 1/13/21 Redness spreads 12cm x 14cm 1/14/21 Bright red spots, fragmented developed. Area is warm to touch. Body temp 97.8 degrees F Patient's son, has set up an appointment with primary MD to be seen
Around 9pm, patient reported swelling at the injection site. Throughout the evening, swelling spread down to elbow, up to should and across the upper chest; became red and warm to the touch and tender. Patient consulted PCP who prescribed an antibiotic and steroid course (unknown specifics as filled at other pharmacy); patient took full dose yesterday and reports decreased swelling, tenderness, but still some heat at the site. Itching is now predominating - recommended to take BENADRYL tonight.
Erythema, warmth and slight induration 3x5cm area around injection site beginning 30 hours after injection and began to fade 72 hours after. Fever up to 101.3 degrees.
Initial information received on 20-Sep-2018 and additional information was received on same day regarding a non-valid unsolicited valid non-serious case received from a nurse. This case involves an unknown age patient who received expired vaccine FLUZONE HIGH DOSE lot UI869AA, expiry date 05-May- 2018 (route, dose and site of administration were not reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expired vaccine used. It was reported that caller updated adverse event information saying the expired product given was Fluzone High Dose and not Quadrivalent. It was unknown whether patient experienced any adverse event following vaccination. 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. Documents held by sender: none.
Left eye is like somebody hit me on the eye; it is all bruise purple and black all over right between inside the corner of nose of the eye; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. Medical history included cholesterol. The patient was taking cholesterol medication. Nothing special other than what you get when you get older. The patient stated that he woke up this morning (19Jan2021), his left eye was like somebody hit him on the eye. It was not the eye but above the eye. It was all bruise purple and black all over right between inside the corner of nose of the eye and all away cross the top of it. He has no idea that come from. There was no treatment for the event. The outcome of the event was not recovered.
Pt reported that started feeling sick with muscle pain in the evening on the same day of administration (Day 0) and had fever and chill overnight; pt drank a pint of water and ASA 325mg. On day 1(7/31/20), pt felt little better but still had fever with 101.4 degrees in the afternoon. On day 2 (8/1), pt felt overexerted with muscle aches but resolved by the afternoon. Day 3 (8/2), pt noticed having sore armpit; which may have been caused by her axillary lymph glands after the immunization in her shoulder. Day 4 on 8/3/2020, pt is feeling back to normal again.
Pain and stiffness in Right Shoulder at vaccination site which never subsided. X-ray taken in February-unremarkable. Physical Therapy began 05MAR19 and is ongoing. Cortisone shot received on 22MAR19 without relief.
administered an expired dose of Tenivac with no reported adverse event; Initial information received on 01-Feb-2023 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 66 years old male patient who administered an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Feb-2023, the patient received 0.50 mL of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Strength: standard) (Frequency: once) (lot U6922AA and expiry date: 22-Jan-2023) via intramuscular route in the right arm for Immunization.  On 01-Feb-2023, the patient was administered an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult  with no reported adverse event (expired product administered).  It was reported that "The clinic is wanting to know do they need to repeat the dose."  Action taken: not applicable.  Outcome: Unknown  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 the 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.
An hour after vaccination, patient developed weakness in her right leg and tingling in her fingers in both hands. By the time she reached home, she experienced chest palpitation and her blood pressure was elevated. She rested at home and drank fluid for one day. Next morning, she experienced headache and dizziness. As it wasn't going away, she went to the emergency at Medical Center where they conducted radiographic test and blood test and found no abnormalities. Patient no longer have those symptoms after visit to the ER at Medical Center.
Had typical sore arm 1-2 days after. Then went away. Started noticing my arm was sore again April 9-10th. However, woke up on April 11th with a high pitched changing ringing in my right ear. Over the course of about 3-4 weeks ringing became louder and more intense. Culminating to such a loud ringing in my ear April 29-May 5 or so. Was so loud I could not get normal sleep for almost a month. Went to see my primary doctor who didn't seem worried about it. Was told it was anxiety. Went to see an Audiologist to have my hearing checked. Hearing was fine. Went to see an ENT and confirmed hearing was fine and no infection. Was told the Tinnitus would go away or not go away. No likely cause.  Over the last 3 months since the loud ringing the sound has abated ever so slightly week by week. I can tolerate quieter environments ever so slightly. I hear multiple tones. At first it was a loud screeching modem type sound. Then that went away/got quieter. Was replaced with a loud EEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEE. That got quieter as well then was replaced with a high pitched hissssssssssssssssssssssssssssssssssss, which has changed/got quieter but is still around. There is a third sound that sounds like grinding metal ever so slight.  I noticed as the sounds dissipated I could pick up sounds that were not audible. I first remember hearing the fridge running, then hearing crickets, to my PC fan etc. As the ringing got quieter I could pick up minute sounds again in my right ear.  Still the ringing is there.
pt recv vax 25DEC97 & 8JAN98 pt exp a fever & a rash w/approx 5 lesions;
Dizzyness, vertigo, headache and muscle aches, rash on arm near shot location
This spontaneous report as received from registered nurse refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB) (dose, route, lot number and expiry date were not reported). The registered nurse stated no adverse effects reported. There was no concomitant medication provided. This is one of one of several reports received from the same reporter. Additional information has been requested.
they provided a patient with their 2nd dose of VAXELIS 26 days after the first dose instead of 28 days.; This non-serious spontaneous safety report, with reference number 2022SA410225 (and inquiry number 01308495), was received by a partner on 05-OCT-2022 and forwarded on 06-OCT-2022, from a health care professional.  Due to the nature of the event the causal relationship between Vaxelis and "they provided a patient with their 2nd dose of VAXELIS 26 days after the first dose instead of 28 days." was not applicable.    Further information is expected.  SIGNIFICANT FOLLOW UP INFORMATION was received on 19-OCT-2022 from a health care professional.  It was reported that there was no adverse reaction following vaccination.  Due to the nature of the event the causal relationship between Vaxelis and "they provided a patient with their 2nd dose of VAXELIS 26 days after the first dose instead of 28 days." was not applicable.   No further information is expected.
BEGINNING ON 11/12/23,  SYMPTOMS INCLUDE SORENESS, REDNESS TO SITE.  WARM TO TOUCH.  HAS BEEN USING ICE PACKS AND TYLENOL FOR PAIN AND SWELLING.
Information has been received from a consumer concerning a 11 year old female patient with a history of hypersensitivity to illosone who in July 2007, was vaccinated with her third dose of GARDASIL vaccine. Since August 2007, the patient experienced severe hives. The patient did not have any reactions with the first and second doses of GARASIL vaccine. The patient has been seen by a dermatologist and a allergist. In either late August or early September 2007, the patient's hands and feet began to swell requiring a visit to the emergency room. The patient has been on prednisone (manufacturer unknown), doxepin (manufacturer unknown), ranitidine (manufacturer unknown), ALLERGRA, and ZYRTEC. The medications were not helping. The patient did not recover from severe hives nor hands and feet swelling. Additional information has been requested.
Ever since I took your 2 shots I have been suffering with anxiety 4 times over now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "Ever since I took your 2 shots I have been suffering with anxiety 4 times over now".  Additional Information: Patient heart sometimes started beating fast for no reason that patient have no idea how that happened. All patient know was that his/her anxiety kicked 10000 times since I took your shot. Patient was writing this asking for help but soon I will look for legal obligations.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient did not have a reaction to the vaccine.  Patient is 11 years old and was given the DTaP instead of Tdap.  The child's Mother was contacted and informed of incident and child will be vaccinated with Tdap sometime before mid August 2022.
Tachypnea, Palpitations, HYPERtension, also c/o feeling jittery, SOB, heart racing generalized tingling & feeling flushed  Narrative: Employee c/o feeling jittery, bilateral leg weakness, tingling, feeling flushed, heart racing and intermittent SOB 10 mins after receiving the second dose of the vaccine. Employee denied cp/dizziness. During observation employee stated that she felt the flushing sensation again and her heart rate elevated to 120 but she denied CP only SOB. She was observed for 30 minutes and taken to the ED via wc for further observation and treatment. 0925- 97.1-73-22-144/69 room air sat 100% orthostatic bp's- 0925- sitting p-73 161/78 sat 100% standing p-74 156/75 ra sat 100%
High Blood Pressure 3/25/2021 BPR 157/101, one dose of Losartan 25mg,  3/29/21 BPR 137/102 While taking two doses am/pm of  Losartan 25mg, Blood pressure is normally controlled with one dose of 25 mg of Losartan
Shot was on Wednesday at 915am. Fever of 101 with migraine, dizziness, and chills - starting Thursday at 3 am. Finally dissipated by 6 am on Friday.  Starting Friday afternoon a large red welt at injection site appeared that is painful if brushed against, hard, swollen, and hot to the touch.
I developed a very itchy red spot near the injection site on saturday (4/10) which I thought was a bug bite but did not see or feel a but bite me. It felt and looked just like a big bug bite. It was very itchy, red, swollen, indurated, and very warm to the touch. It increased in size overnight and the next day (yesterday 4/11) it was still very warm and itchy and seemed to increase in severity yesterday afternoon. Therefore, I circled the area with a marker last night to evaluate if it was continuing to expand but today the redness remains within the circled boundaries. It is less warm and less red but still visible. I put hydrocortisone cream on it for the itching last night. The spot itches less today and is less swollen but is tender to touch.  Overall, it feels better and I thought it was just a bad bug bite but then saw that people receiving moderna vaccines have had similar reactions so I figured id report it.
Pt vaccinated with Heptavax-B developed angioneurotic edema, urticaria, pruritus, bronchospasm, episodes of flushing, arthralgia, erythematous macular rash thought to be erythema multiforme. Seen in ER given cortisone. Wheezing persisted.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 13th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 61 days after receiving SHINGRIX, the patient experienced shingles, rash, tingling sensation and hives. On an unknown date, the outcome of the shingles was unknown and the outcome of the rash and hives were recovered/resolved and the outcome of the tingling sensation was not recovered/not resolved. It was unknown if the reporter considered the shingles, rash, tingling sensation and hives to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was previously reported to a physician. The patient received the SHINGRIX on the left arm. The patient reported that, after two months after receiving the SHINGRIX, the patient experienced rash across ribs which looked like hives or welts. The patient reported that, the rash lasted for approximately 1 week and then subsided. The patient reported after the rash subsided, the patient noticed a tingling sensation that which was in the same area where the rash was located. The patient stated that she noticed the tingling every day. The patient states that she went to visit visit her dermatologist and he was concerned that, she had an outbreak of Shingles and wanted to prescribe medication, however, the patient did not want to take medication. The patient had limited contact information for her healthcare professional (HCP) at the time of the call.
Injection site soreness; joint pain; headache;  low grade fever (99.4).   Symptoms slowly  came on and were mostly gone by 36 hours following injection of vaccine.
Redness and itching at shot site. 3.5" X 3.5" surface area.
Patient has a red rash that has spread in size on his upper right arm he states that is where the immunization was given.
heart palpitations/fluttering, tightness in neck and shoulders, shortness of breath, dizziness, exhaustion.  Mostly occurs at night and in the morning.
Pt recd 2 doses vax (1cc) 18FEB91 & 18MAR91; p/2nd dose devd numbness & weakness of left arm; symptoms worsened on 19MAR91; rx'd w/physical therapy; exp'd complete recovery; MD dx "post vax brachial plexus neuritis"; recommend no more vaxs;
a dose of PEDVAXHIB was reconstituted with 0.7ml of Merck Sterile Diluent and administered to a patient; No additional AE reported; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot number T037650, expiration date 21-JUL-2023 (dose and route of administration were not reported) for prophylaxis that was reconstituted with 0.7 milliliters of sterile diluent(MERCK STERILE DILUENT) (lot number and expiration date not reported) (product preparation issue). No adverse event was reported.  This is a non-valid case due to the lack of patient identifiers.  This is an amended report. This case is a non-valid report but it was distributed in error. Case being re-sent to notify all recipients.
Since Wed. Swollen left upper arm and reddened approx 5x10cm area stayed same site is wamr and sensitive to touch.
HEADACHES, CHILLS, FEVER, NIGHT SWEATS, BODY ACHES, GENERAL MALAISE FOR 4 DAYS  FOLLOWING VACCINATION.
injection given 1/20 on 1/28  sister developed redness and warmth at the cite encompassing upper left arm cool to warm compresses tylenol temp bid and monitor
20Jul90 pt vax w/ 2nd hepta B; that pm pt exp diarrhea, fever, h/a, chills.
Patient stated that starting the day following the receipt of her 1st dose of Pfizer vaccine (12/2/21) through today (12/10/21), she has been experiencing some tingling, numbness, and hot and cold flashes. She said it is throughout her body and not just on the side where the vaccine was administered
This spontaneous report as received from a registered pharmacist refers to a 12 years old female patient. The patient was vaccinated with three dose series of GARDASIL (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that since on an unknown date, the patient had been having menstrual bleeding for three continuous weeks, which had been heavy at times. At the time of the report, the patient had not recovered. Additional information has been requested.
Headache and fever that led to an intense migraine causing nausea and vomiting.  Muscle tightness, headaches, sore arm. The worst being the migraine that was so intense I would have gone to the hospital could I have drive or had insurance to pay for it.
She reports that her left shoulder (received vaccine in left deltoid) has been very sore since she's received the vaccine (4 weeks ago), and x1 week has now had left 5th finger numbness. No known trauma to left shoulder/arm other than flu shot.
Minor Aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Minor Aches) and HEADACHE (headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 006B21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (Minor Aches) and HEADACHE (headache). At the time of the report, PAIN (Minor Aches) and HEADACHE (headache) outcome was unknown.            Action taken in response to m-RNA1273 was considered to be not applicable.
One week post injection, complain of achy arm where injection was given, difficult to raise arm, no swelling or redness at injection site.
Information has been received from a physician concerning a 31 year old female nurse who on 17-FEB-2009 while she was orally administering a child with 2mL dose of ROTATEQ, the child spit out solution into nurse's eye and then she experienced blurred vision.  The patient sought unspecified medical attention.  Additional information has been requested.  This is one of two reports from the same source.
The morning after vaccination, patient woke up with chest pain, extreme body aches and fatigue. She reported headaches and shortness of breath, chills, no fevers.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from a practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 08-FEB-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N021475 and expiration date 03-JAN-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
chills, severe headaches, sore muscles, sick at stomach, lifeless, eye balls hurt, just like flu symptoms. Took 4 days to recuperate.
Approx. 4 hours after vaccine, right arm started to ache. By 8:30 pm, she was unable to move her right arm. Movement of the arm got extremely painful to move from 12/07/01 pm thru 12/09/01. No treatment.