chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient was given RECOMBIVAX HB and PROQUAd that expired; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent with lot number W026513 and expiration date 15-APR-2025.  On 19-DEC-2022, the patient was vaccinated with expired vaccines including hepatitis b vaccine (recombinant) (thimerosal-free) (RECOMBIVAX HB) lot number U008328 with expiration date 16-DEC-2022 and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) with lot number U019285 and expiration date 15-DEC-2022.  The administered vaccines had not experienced temperature excursions prior to the date of administration and no adverse events or product quality complaints were reported.
It was reported in a news magazine article that a male who on an unspecified date was vaccinated with a dose of MMR II. Subsequently the patient developed autism. The patient's mother blamed her son's autism on MMR II. The patient's mother reported that they were curing her son's autism "with diet and chelation, a process that chemically binds heavy compounds in the body so they can be excreted". Upon internal review, autism was considered to be other important medical event. No further information is available.
Hair loss - began approximately 3 months after the 1st injection.  Hair loss continues to this day
Initially 2 to 5 days just fatigue. Evening of March 26th  unusual fatigue and lower back to middle back discomfort low pain level.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Feb2021 at 10:00 as dose 1, single (Lot number: EL9216), in left arm, on 15Mar2021 at 15:00 as dose 2, single (Lot number: EN6283), in left arm, on 20Aug2021 at 17:00 as dose 3 (booster), single (Lot number: SC3181), in left arm and on 09May2022 at 18:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin; Macrodantin, reaction(s): "Known allergies macrodantin", notes: Known allergies macrodantin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Sep2022) Positive, notes: I tested positive again for Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: 10 days after her final dose of Paxlovid, Covid-19 symptoms returned in full force and she tested positive again for Covid. This was after 10 days of feeling completely well.
Medical assistant reported he mix ACTHIB 0.5 ml with saline dilutant instead of the dilutant that goes with ACTHIB and immunized the pediatric patient. No adverse reaction reported. Can slow down and verify you have the right dilutant that goes with the right vaccine to prevent this error from occurring again. Outcome: No adverse reaction reported.
Pharmacist administered dose from Pfizer Covid 5-11 vaccine vial WITHOUT DILUTING with the required 1.3ml normal saline. By my calculations, patient received dose of 23mcg instead of the appropriate 10mcg active ingredients. CDC consulted.  I was informed that patient was more likely to have soreness at injection site, but not at increased risk of any other serious side effects.  Mother of patient was informed.  Counselled regarding increased risk of sore arm, and recommended acetaminophen to treat if it occurred.  Will follow up in three days to confirm no further ill effects.
Pt awoke early in morning of next day crying w/fever of 101-102 R & leg swelled from hip to knee; Taken to pvt MD & mom was told this is a normal rxn to DTP shot;
Symptoms first noted upon getting out of bed on 10/19/09.  Symptoms were not present upon going to bed the night before.  When I woke up on 10/19/09 I had a rash to my face & neck.  I also had facial swelling & urticaria. I was running a low grade fever (100 - 100.7).  My face & neck felt like it was burning.  It was very red & blotchy.  I began taking Benadryl which did help alleviate some of the symptoms.  On 10/20/09 I was given Kenalog 40 mg IM.  As of today, I still have some facial swelling & I still have the rash to my face & neck though it appears to be slowly resolving.
Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after reciving vaccination patient stated they "felt weird", reported nausea and shortness of breath, and were found to have a blood pressue of 200/96 mmHg despite taking blood pressure medications that day. Patient was transported to the emergency department during which they had a brief episode of unresponsiveness and were non-interactive. On initial exam in the emergency department patient symptoms were improving: speech, sensation, and cranial nerves are intact, normal strength in all extemities, lungs are clear, and there is movement in all extremities. No rash, wheezing, or respiratory distress noted. Repeat vitals within normal ranges except blood pressure 151/87. Patient administered medication for nausea. Symptoms resolved and patient discharged to home stable.
Severe stomach cramps, headache for 18 hours, lethargic, vomiting, 103.6 fever, muscle spasams in legs.  11/5/09:  Vaccine record received, VAERS updated. 11/6/09:  Record from Florida Poison Information Center Network on 11/1/09 documenting a call from the mother of a patient who received the H1N1 vaccine and developed muscle aches, fever and abdominal pain.  Florida Poison Information referred them to a local ED where they were seen and the child was diagnosed with:  Abdominal pain & Pediatric Viral Syndrome.
After 2nd dose 7 hours later she report chills and extremely cold, vomiting 3x same night of the vaccine, night sweats, and stool was liquidity. One time she had nose bleed and coughed blood and once had blood in her stool but it only happened once and cleared since
COGNITIVE MEMORY RECALL ISSUES; EYE SWELLING; CHILLS; HEADACHE; FATIGUE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced cognitive memory recall issues. On APR-2021, the subject experienced eye swelling. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cognitive memory recall issues, eye swelling, chills, headache, fatigue, and fever on APR-2021. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Vaccine site a little swollen; Coughing - pt states she wheezes when she coughs. Chills/shivering; Light headed with standing up once today; Pt does not want to get the second dose of SHINGRIX.  RN informed pt that these symptoms are common after receiving the vaccine. Supportive care is recommended for symptoms.
Pt. complained of right arm and  right axilla swelling. Pt.'s mother states she is taking her to PCP today.  Symptoms started morning after
Local soreness in left deltoid, redness, swelling, slightly warm to touch, nickel size area became hard, started draining yellow puss like substance on 09/23 and continued to drain for a week. Seen in an ER. No antibiotic, "just let it drain".
Patient's daughter called. Upset mom's arm is in severe pain still. Also complaints about the injection site (says too high). Wants to take patient into MD.
I woke up at 0300 AM with ringing in both ears, aka, Tinnitus. It still persists.
Headaches, dizziness, myalgias, arthralgias, nose bleeds, nausea, GI distress. After approx one week of symptoms she was seen in the ED for evaluation. Normal workup. Managed symptomatically. By 2 weeks her symptoms were gradually resolving and nose bleeds had stopped.
No additional AE; vaccines were administered after experiencing temperature excursion; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medication was provided. On 07-OCT-2021, the patient was vaccinated with incorrectly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T032317 with expiration date on 22-SEP-2021 (dose and route of administration were unknown) for prophylaxis. No adverse event was reported. The vaccine underwent the temperature excursion of 11.9 degrees Fahrenheit for 1 hour, also reported as 1 hour and 18 minutes.
Patient received the Johnson and Johnson vaccination on 4/6/21 from facility. The patient presented to pharmacy for COVID-19 vaccination on 5/13/21 and received the first dose of Pfizer vaccination. The patient reported that a vaccine was given in April for the flu shot. Unknown if Rph who administered the vaccination checked the online system to verify if patient was previously vaccinated .  When checking system on 6/16/21, the pharmacy noted this possible error. The pharmacy attempted to contact the patient and the phone number provided was no longer in service.
Initial report received from a health care professional (nurse) on 22 Jun 2010: This patient was vaccinated with only the diluent portion of MENVEO (batch number: 090901), (dose: unknown) intramuscularly on 22 Jun 2010. The lyophilized portion was not reconstituted. No adverse event was reported following this administration. Follow-up report received from the nurse on 07 Jul 2010: This patient was vaccinated with MENVEO at dose 0.5 ml on 22 Jun 2010. It was reported that, the patient planned to receive MENACTRA in Dec 2010 with second dose of HAVRIX. No other information was provided.
Information regarding PREVNAR was received from a healthcare professional regarding a male patient who received 2 doses of PREVNAR at 4 months 20 days, then again 4 days later. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. The patient received 2 doses of PREVNAR at 4 months 20 days, then again 4 days later. At time of report, no adverse event had occurred.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 1 ml. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 14th August 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced overdose. On 15th August 2018, the patient experienced injection site pain and injection site erythema. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the overdose and product supply issue were unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient's paperwork from pharmacy stated that she received 1.00 ml dose of SHINGRIX vaccine in the left deltoid, which led to an overdose. On 15th August 2018, next day after vaccination, the patient experienced pain and redness at the site of injection which lasted for 2 weeks. The patient had not been able to get the 2nd dose due to availability issue and would follow up with her pharmacy to make sure if she received the correct dosage. The patient's Pharmacy was telling her that they would get the vaccine, but they were not getting it and would not get it any time this year. The patient was looking if she would get 2nd dose of SHINGRIX anywhere around town. The patient was worried about the delay in 2nd dose, even though there was a demand of SHINGRIX. It appeared that the events were reported during the call. The reporter did not consent to follow-up. No further details were provided.
started to experience a rash on the arm,, itchiness; started to experience a rash on the arm,, itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (started to experience a rash on the arm,, itchiness) and VACCINATION SITE RASH (started to experience a rash on the arm,, itchiness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included MIRTAZAPINE for Depression, VITAMINS NOS and ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for an unknown indication.   On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced VACCINATION SITE PRURITUS (started to experience a rash on the arm,, itchiness) and VACCINATION SITE RASH (started to experience a rash on the arm,, itchiness). At the time of the report, VACCINATION SITE PRURITUS (started to experience a rash on the arm,, itchiness) and VACCINATION SITE RASH (started to experience a rash on the arm,, itchiness) outcome was unknown.            No treatment medication was provided.  The patient reports having no problems with the first 2 doses. The rash was a pretty good sized rash.
lymph node swelling in right armpit; Vaginal spotting; This is a spontaneous report from a non-contactable consumer (patient).   A 30-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 12Mar2021 08:30 (Batch/Lot Number: EN6206) as single dose at the age of 30-year-old for COVID-19 immunisation, administered at hospital.  Medical history included seasonal allergy. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA); fluticasone propionate (FLONASE), both taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 19Feb2021 08:15 (Batch/Lot Number: EM9810) as single dose at the age of 30-year-old for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. The patient experienced lymph node swelling in right armpit (non-serious) on 13Mar2021 with outcome of unknown, vaginal spotting (non-serious) on 13Mar2021 with outcome of unknown.  No treatment received. COVID was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
the patient fainted 5 minutes after receiving the vaccine.  She hit her head on the floor when she fainted.  We laid her on her back and elevated her feet.  We put ice packs on her wrists and the back of her neck.  we continued to monitor her for 30 minutes.  She felt better when she left, however her head did hurt.  We recommended that she seek further medical care to be evaluated since she did hit her head.
This spontaneous report as received from a nurse refers to a 77 year old male patient. Pertinent medical history, drug reactions/allergies and lab diagnostics studies were not reported. On 14-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # K004148, expiration date 10-MAY-2015),  0.5 ml, intramuscularly. Concomitant medication was not reported. On 14-OCT-2014, after receiving PNEUMOVAX23, the patient experienced pain at the injection site that radiated into the shoulder. The adverse event was treated with orally codeine. The outcome of the event was unknown. The patient sought medical attention by saw nurse. This is one of two reports received from the same source. Additional information has been requested.
8/5/2021  around 9:30 pm pt felt weak, said eyes were blurred, then lost complete vision, panic attack, stammering and slurring words. Took to area. CT scan normal. Treatment for a severe acute migraine. Vision blurred until August 7th.
Had the usual sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history included: "heart trouble" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (First Dose: 14Jan2021 NDC, LOT, EXP: Unknown), administration date: 14Jan2021, when the patient was 82-year-old, for COVID-19 immunization, reaction(s): "Had the usual sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Had the usual sore arm".  Additional information: With the original 2 vaccines, the injections, really had nothing more than usual. They were all Pfizer. Had the usual sore arm and nothing else. Did not have any real problems with first 2, original doses Covid vaccine. Had a little sore arm but not bad. Has got several medical conditions and is on gobs of medicine. No Family Medical History Relevant to adverse events.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201240528 similar report from same reporter;US-PFIZER INC-202201240238 similar report from same reporter;
7MAR94 pt recvd vax in AM site of inject became red & warm that evening & pt cried for 2 hrs straight; slept through noc; fussy entire next day only consolable if mom held;
injection site pain, sore throat  Narrative: Employee reports injection site pain/discomfort, redness, swelling, and itchy, as well as itchy sore throat which all began the day after receiving the vaccine. Reports area around injection site was warm to the touch and was unable to lay on that side. Reports all symptoms have resolved.
Needle/syringes was "faulty" and the person administering the shot wasn't sure if the vaccine went "into" the arm.  Wanted to give another dose immediately.  She mentioned that the needles they are given for the COVID vaccine were faulty and this type of event happens frequently.  We decided to wait to have another shot to see if I had an immune response to the vaccine in the next 24 hours (sore arm, etc).
Arm felt weak with extended reaches and handling objects using left are yet on 10/29/2009
I had the normal sore arm after receiving the vaccine and I was tired for day. I started feeling sick on 12/21/2022 with a really sore throat down low. I throat it was reflux and treated it like it was reflux. As the day progressed, my symptoms got worse. My nose was running, and I went through tissues like crazy. I felt really bad, and I felt out of it. I tested positive with a home test on 12/22/2022. I contacted my doctor, and I was given the prescription PAXLOVID. I had a metallic taste in my mouth, and I had diarrhea on Christmas day and the day after. I did have a rebound of COVID-19 and was sick again for six whole days. As of today, I feel that my asthma is worse since having COVID-19. I have to use my inhaler more than I did prior to COVID-19.
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PYREXIA (fever) and MYALGIA (aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue), PYREXIA (fever) and MYALGIA (aches). At the time of the report, FATIGUE (fatigue), PYREXIA (fever) and MYALGIA (aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
I experienced an adrenalin allergic reaction 3 days following the injection.  (The 1st 2 days was extreme fatigue).  My heart was racing, thoughts racing, talking and reacting very hyper.  This lasted approximately 10 days and now experiencing extreme fatigue - it is debilitating and interferes in daily life.
Fever up to 103 degrees, fussiness, stomach cramping, vomiting, diarrhea, very hard to sleep, staring spells also. Lasted 3-5 days. Vomiting first 2 days.
Fever, chills, aches and pains in joints, slight nausea, big rash at injection site.
chills after 2nd dose.  Lasted for approximately 8 hours but resolved after taking motrin; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 14Feb2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's has no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took BNT162B2 dose 1 via an unspecified route of administration on 24Jan2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. It was reported that chills after 2nd dose on 14Feb2021. Lasted for approximately 8 hours but resolved after taking motrin. The outcome of the event was recovered on an unspecified date.  Information about lot/batch number has been requested