chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case involves a patient of (unknown demographics) who were vaccinated with suspect product INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] were activated on 20-Nov-2021 (product storage error) and reconstituted product stored and administered to patient on next day (wrong technique in product usage process) with no reported adverse event. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant vaccines were not provided. On 22-Nov-2021, the patients received a 0.7mg {total} dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number UJ773AA and expiry date was not reported) via an unknown route at an unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to incorrect product storage and wrong technique in product usage process (latency was on same day). At the time of report, no adverse event reported. Event outcome was 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 Directive 2001/83/EC and Module VI. 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.
full body hives for 5 days  wheezing on and off for 36 hours treatment ; Benadryl,  Prednisone
As soon as I got the vaccine my arm was swollen up and started itching and I walked around the store 15 minutes. I told them that it was mildly itching after 30 minutes, they said it would go away. The itch progressively  got worse and started itching in different places, by Sunday it was really worse and the hives started breaking out on me. I went back to the pharmacy and they told me to take some Benadryl and the bumps went away but the itching didn't stop. On Monday I went to the doctor and he gave me a shot of steroids in right hip and after a while it stopped and I got a prescription for the itching. The pharmacist said they would not give me the next dose because of the reaction.  I am short of breath as well and will see the doctor on Friday for the SOB
Immediately after vaccine dose 1, patient had lips feel number and tongue itch, dizziness and unable to stand after multiple attempts. Patient observed for 30 minutes. For two days after vaccination patient experienced fever 102.4, tongue swelled up and fatigue for two days. Treated with Benadryl after vaccination and the two days after. Prescriber recommended to patient to not go forward with dose number 2.
Did fine immediately after receiving the vaccine. Later that evening at 1045 pm, was talking on the phone when she felt her lips and throat swelling up. Progressed to L sided facial swelling w/some SOB. No dysphagia. Went to the ED and was treated with benadryl 50 mg IV, decadron 10 mg IV and pepcid 20 mg IV. Sxs improved and pt was subsequently d/c'ed home with prednisone 60 x 5 days and benadryl 50 mg daily.
Information has been received from a consumer concerning her son, a 15 to 18 month old patient with a mild form of cerebral palsy who was vaccinated with the first dose of MMR II. One hour post vaccination, the patient experienced "like seizure activity with left side of his face lowered". The child also experienced fever and rash and had a hard time to maintain eye contact. The patient's mother stated that she worked very hard with her child's "mild form of cerebral palsy" and his delays, but after being vaccinated with MMR II the child regressed. The reporter stated that the adverse effects continued on and off form many months after the MMR II vaccination. The patient's mother wanted to take her son to the doctor's office for follow up but then he would get better. It was reported that the patient was also hospitalized with rotavirus for 5 days, right before he was 3 years of age. Which she thought was due to the patient's weakened immune system because of the MMR II that was administered when the patient was younger. The patient did not receive the rotavirus vaccine because his doctor did not think it was good for him to get it. The mother stated that he "child's immune system was back to normal". The outcome for fever, rash, cerebral palsy regressed and rotavirus was unknown. Upon internal review seizure like activity was considered to be an other important medical event. No further information is available.
Numbness of her foot fingers; Soreness of injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Numbness of her foot fingers) and VACCINATION SITE PAIN (Soreness of injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, SIMVASTATIN and LORATADINE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness of her foot fingers) and VACCINATION SITE PAIN (Soreness of injection site). At the time of the report, HYPOAESTHESIA (Numbness of her foot fingers) and VACCINATION SITE PAIN (Soreness of injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was provided as cold clean cloth for soreness in the injection site as advised by CDC.
This case was reported by a other health professional via sales rep and described the occurrence of pain in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 12th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced pain and swelling. On an unknown date, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the pain and swelling were recovering/resolving and the outcome of the incorrect storage of drug was unknown. It was unknown if the reporter considered the pain and swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by an office manager. The patient received SHINGRIX which was frozen, which led to incorrect storage of vaccine. The only side effect the patient experienced was pain, soreness & swelling but was better after 3 days.
Patient reported swelling of the throat and swallowing difficulty after vaccine.  Patient was given Benadryl 50mg oral and dexamethasone 50mg IM.  No resolution of swelling, HR dropped from 68 to 48. Patient escorted to Emergency room for further treatment where he received  iv famotidine and po Zyrtec.  Discharged home, resolved. Returned to clinic two days later for recheck with provider.
allergic vasculitis; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age (Age: 66; unit: unknown) received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. It was reported that the patient had one dose of the pfizer covid 19 vaccine and had a body rash that was diagnosed as allergic vasculitis. The patient had been advised to not get the second dose. The patient wanted an opinion on getting the second dose and wanted to know how long the side effect might last and are there long term effects. The patient also asked if he can take the Johnson and Johnson vaccine after having taken the Pfizer covid 19 vaccine, is there an interaction between the vaccines and if after having one dose of the vaccine, what coverage does he have. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Ataxia and aphonia approximately 8-9 hours after getting the vaccine. Symptoms resolved overnight and patient is able to walk/walk the very next day with slight discomfort. Patient believes it could be cause by his previous history of Lyme disease even though his symptoms were completely resolved at the time of the vaccine.
The day after getting the vaccine, I was aching all over and just felt lousy, and just wanted to lay around.  My left arm, which I had the shot in, was extremely sore and uncomfortable to even sleep on for the first two days after the shot and then still very sore for at least 4 days as far as touching the site and moving the arm around. About one week to two weeks after the shot, I got two small blisters at the injection site.  They didn't bother me but other than itched a little.  The spots took a coupe of weeks to completely go away.  About a week after the two spots at the injection site appeared, I got two more small spots on my right side near my stomach.  They didn't blister as much as the two on the arm, they were just red and they didn't really bother me at all.  They cleared up within a week or so. I didn't do anything about the areas other than just watch them to be sure they didn't get any worse and tried to not scratch the ones on my arm so that they didn't pop.  I was afraid if they popped, they might make more or get infected.
I started with a low grade fever and cold symptoms and then a throbbing headache in a previous concussion site and it just started pounding in that and I was prescribed Paxlovid and knocked all the could symptoms out within two days although the headache continued and progressively got worse and I have had migraines unable to get out of bed never before experienced and this continued for three months before seeing a neurologist then I had to wait three weeks before he injected me with Botox to relieve the pain prior t that I was prescribed Gabapentin it made the brain fog worse and I began to have severe panic attacks and with the first set of Botox injections it helped some and then another set three months, IT WS HORRIFIC AS i libe by myself I hasp withdrawal symptoms on top of the other stuff no appetize I could no longer sleep favorite foods tasted horrific every three months I get my Botox shots and they  seem to headaches a other pains but then I've gotten vertigo since March and wafting to see a vestibular OT long wait to get anything to get it taken.
tingling sensation on the left side of her face; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 19Jan2021 09:50 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine today at 9:50am and experienced a tingling sensation on the left side of her face at 10:30-10:45am 19Jan2021. It was described as like she had gotten Lidocaine and it's not worn off yet. The sensation was not getting worse but was still there. She was asking if this a normal reaction and on what she should do.   Information about lot/batch number has been requested.
first dose of Moderna COVID-19 vaccine on 27-JAN-2021 an second shot was 20-FEB-2021; A spontaneous report was received from a consumer who was a 40-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced first dose of Moderna COVID-19 vaccine on 27-JAN-2021 an second shot was 20-FEB-2021 (inappropriate schedule of vaccine administered).   The patient's medical history, was not provided by the reporter.  No concomitant medications were reported.  On 27-Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20-Feb-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection. She reported that she had one rabies shot on 27-Feb-2021 and a second one on  02-Mar-2021.  She reported that she was feeling fine and had no side effects.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event, inappropriate schedule of vaccine administered, was considered recovered/resolved.  Follow up received on 26Mar2021 included no new information.; Reporter's Comments: This report refers to a 40-year-old, female patient, who experienced who received first dose of Moderna COVID-19 vaccine on 27-JAN-2021 (013L20A) and second shot was 20-FEB-2021 (023M20A.  The second dose was 24 days after the first dose (inappropriate schedule of vaccine administered). There were no reported AEs associated with this case of inappropriate schedule of vaccine administered.
Redness and swelling at injection site. This happened at the time of injection then went away and came back = 1 week after injection & is still there.
The next day after the booster when I woke up , went to the bathroom and  put the light on, the room seems full of fog, very scary! it dissipated after a few minutes Since then it is much lighter but in the 1st minutes I put the lights in the morning, there is a slight foggy look in the room. I did not have any after effect after the 1st 2 shots of the Pfizer vaccine And now I am concerned about having a second booster,  what is your suggestion?  I did have Covid  in October 2011, had some fever under 100 for 2 days
Nerve pain in all of my skin (including hair follicles and teeth); extreme headache; 101 degree fever; lethargy; shivers; slept for 17 hours on and off; numbness in my face and fingers; numbness in my face and fingers; zinging pain in my teeth; This is a spontaneous report from a contactable Other HCP. This 40-year-old female Other HCP (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL9267) via an unspecified route of administration from 11Feb2021 at 03:00 pm to 11Feb2021 at 03:00 pm at single dose (dose number; 2) on left arm for covid-19 immunisation. Vaccine facility type was reported other. Patient was 40 years old and not pregnant at the time of vaccination. Patient's medical history included Known allergies: Sulfa (unspecified dates). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL9262) via an unspecified route of administration from 21Jan2021 at 3:30 pm to 21Jan2021 at 03:30 pm on left arm at single dose (dose number; 1) on left arm for covid-19 immunisation. Concomitant medications included (other medications in two weeks) Ibuprofen and ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN-C) and birth control from an unspecified date to an unspecified date at unknown dose and frequency for an unspecified indication. If other vaccine in four weeks; no. On 12Feb2021 at 02:00 pm, patient experienced nerve pain in all of her skin (including hair follicles and teeth), extreme headache, 101 degree fever, lethargy, and shivers. This hit her at almost 24 hours after injection. She slept for 17 hours on and off. She awoke this morning with numbness in her face and fingers, but also zinging pain in my teeth. The reported adverse events did not result in emergency room or physician's office visit. Treatment received was reported as no for the adverse events. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The outcome of events was recovering.
Vaccine was at room temperature for 20 hours, which exceeds recommendations. Advised patient we would check with manufacturer for any guidelines on how to proceed.
Sore arm at injection site within 6 hours, lasting about 24. 48 hours later - fatigue, GI issues. 5/23/22 tested positive for COVID - congestion, runny nose, sore throat. Some leg & chest cramps - intermittent and mild.
114/72, 99 Pulse ox, heart 68. Pts. mono alerted nurses to fire rescue that boy was dizzy/lightheaded.  His fitals were checked and drank water.  He instantly began to feel better and refused further treatment.
Started with pain at site - bruised (gone now) sorer on 3rd day. Hurts worse if raises arm. Pain hasn't gone away muscle where shot given to elbow painful. No swelling. Better when ices.
Low-grade fever in the morning of 11/12/17, given 1 dose of Tylenol 9am, 1 dose of Ibuprofen 11am,  acting normally all day without any issues; fell asleep on our family room carpet and within 10 minutes was found not breathing/unresponsive, TIME OF DEATH 8.05PM.
AFTER VACCINES, PATIENT WAS PALE, FELL AND HAD SOME TWICHING. DID NOT LOSE CONSCIOUSNESS. PATIENT RESTED IN ROOM. GIVEN LIQUIDS TO DRINK. AFTER 25 MINUTES, PATIENT'S COLORATION NORMAL. VITALS NORMAL.
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves male patient of an unknown age who experienced tingling in the left arm and numbness in the left arm, while he received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in the left deltoid (dose and expiry date not reported). On an unknown date, patient developed a non-serious tingling in the left arm and numbness in the left arm lasted a short while following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Other relevant tests included no lab data. Final diagnosis was numbness in the left arm and tingling in the left arm. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. List of documents held by sender- none.
Patient was found to be influenza A positive.  Ultimately discharged to home, with return to ER 12/29 due to worsening symptoms.  At that time requiring 4L nasal canula (baseline 2L), febrile, lethargic.  CXR without focal infiltrates. She was admitted to Hospital for further cares. Since her admission has had progressive somnolence and increasing oxygen needs, copious secretions and emesis. Transferred to another Hospital; Viral sepsis (HCC) with acute on chronic respiratory failure. Treated and then discharged to a group home. ED visit and hospitla admissions within 6 weeks of receiving the COVID vaccine.
At approximately 1 1/2 hrs after vaccine, feet and hands were tingling and I had vertigo and became somewhat dizzy.  It occurs when I am standing or walking.   In addition,  my feet have swollen with the right foot being more swollen than the left.  Today is day 6 after the vaccine and this is continuing.  I have never experienced any vertigo or dizziness before.  Note I am 74 years old. I called my PCP who suggested I get some Bonine.
12PM Pain at site, neck, back, chest - dyspnea. Fever 102, confused, weakness on left, nausea.
Red, fever, painful. 3rd day reaction.  Swelling at site of injection.
1 of 3 pts who recvd vax devel swelling of approx 3 inches in diameter @ the inject site; resolved-no treatment initiated;
I suffered what seemed to be a seizure on Friday 2/24. It was witnessed by my adult daughter. I was seated on a sofa, my eyes closed and I lost consciousness. My daughter reported that my arms went back and forth as did my head. I woke back up and felt dizzy but fine otherwise. I have never had a seizure or anything like that happen to me on the past. I did have all flu like symptoms (fever, chills, body aches, headache) 12 hours post vaccine which I expected to happen. All of these flu like symptoms  occurred 2/23 and were essentially gone by 2/24.  I am not reporting the flu like symptoms as ?adverse ?. I am simply reporting the seizure like activity that occurred approximately 1:00 pm  on 2/24.  I did not seek medical attention but I am following up with my doctor. No more seizures have occurred.
Rash on face arms chest.  Patient presented 3 days following vaccine administration to ED.  Prescribed Pepcid AC 10mg tablet by mouth two times a day, Orapred 15 mg/5 ml- 10 ml by mouth two times a day, Hydroxyzine hydrochloride 10 mg/5 ml - give 7.5 ml by mouth PRN up to 4 times daily.
Weakness, numbness, (L) arm pain, neck pain, lower ext on (L) arm pain, limited range of motion.
Vaccine vial MAY have not been diluted prior to use, as a result the patient may have received a higher than approved dose. Parent/Caregiver was notified, no concerns or adverse effects noted. 2nd dose 04/27/22 may also have been affected.
PATIENT RECEIVED MODERNA DOSE  AFTER JANSSEN VACCINE; This spontaneous report received from a health care professional concerned a male of unspecified age. 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 JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included mrna 1273 for prophylactic vaccination. On 29-JUL-2021, the subject experienced subject received moderna dose after janssen vaccine. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of patient received moderna dose after janssen vaccine was not reported. This report was non-serious.
This spontaneous report was received from a Registered Nurse refers to a patient of unknown age and gender. On 13-JAN-2014, the patient was vaccinated with the first dose of RECOMBIVAX HB 1 ml, intramuscular. On 12-FEB-2014, the patient was vaccinated with the second dose of RECOMBIVAX HB 1 ml, intramuscular. On 20-MAR-2014, the patient was vaccinated with the third dose of RECOMBIVAX HB, 1 ml, intramuscular. On 20-MAR-2014, the patient received their dose of RECOMBIVAX HB "too early". No adverse effect reported. The outcome of the patient received their dose of RECOMBIVAX "too early" was unknown. Additional information has been requested.
headache lasted 2 to 3 days; 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 HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-094881 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-094881:
Difficulty administering vaccine secondary resistance. Student reported immediate pain in areas radiation about 1 our later presented back to clinic with c/o diaphoresis, nausea. Allowed to lie down - sx improved. 1/6/14 after Christmas break, returned static, still with pain to (L) deltoid - improving slowly but pain decreased ROM (L) shoulder per mom.