chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was given the Hib powder portion of Pentacel that had been reconstituted with sterile water rather than the DTap-IPV liquid diluent with no adverse event; Initial information received on 12-Apr-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 1-year-old female patient who was given the hib powder portion of pentacel that had been reconstituted with sterile water rather than the dtap-ipv liquid diluent with no adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13v (crm197) (prevnar 13) for Immunisation.  On 08-Apr-2022, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine with unknown dosage form and strength with lot number UJ591AA and expiration date 18-Dec-2022 via intramuscular route in the left thigh for immunization.  On 08-APR-2022 the patient was given the hib powder portion of pentacel that had been reconstituted with sterile water rather than the dtap-ipv liquid diluent with no adverse event (product preparation error) during the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  It was reported "office supervisor states that a medical assistant recently noticed that there was still one liquid DTap-IPV vial of PENTACEL remaining in the box and discovered that a patient was given the Hib powder portion of PENTACEL on 08APR2022 that had been reconstituted with sterile water provided by Varivax rather than the DTap-IPV liquid diluent from the PENTACEL box. Caller wanted to know whether the Hib portion would count as valid or if the patient needed to be revaccinated with PENTACEL".   Action taken with diphtheria, tetanus, ac pertussis, ipv and hib vaccine (pentacel) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient was given the Hib powder portion of Pentacel that had been reconstituted with sterile water rather than the DTap-IPV liquid diluent with no adverse event).  At time of reporting, the outcome was Unknown for the event patient was given the hib powder portion of pentacel that had been reconstituted with sterile water rather than the dtap-ipv liquid diluent with no adverse event.  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.
Approx 10-15 minutes after receiving the vaccine, client started c/o feeling shaky and overall jitteriness, and elevated blood pressure. She was monitored for several minutes and started feeling better. She admits to being nervous to take the vaccine and has had several episodes like this before after vaccines. She was steady enough to drive herself home and she went to bed for a few hours and woke up feeling fine except for a sore arm for 2-3 days. Had physical 3 days after this episode and he said she was fine.
Dizziness and brain fog.  Brain fog lasted for about 7-8 days.  Dizziness lasted about 13 days.
I received my vaccine on 05/10/2022 at the pharmacy. 24 hours after dose I experienced malaise, achiness, chest congestion and fever. I went to urgent care on 5/17/2022 at 10 AM and was diagnosed with bronchitis. Symptoms continued and fever was getting worse. I made a second visit to urgent care on 05/31/2022 at 10 AM and during that visit I was prescribed doxycycline. As of today I am still having symptoms. I have had 5 Covid test which were all negative.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; ENTIRE LEFT ARM FROM SHOULDER TO THE ELBOW ON THE LEFT SIDE HURT; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection in JAN-2020 (recovered on her own). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A or could be GU1A21A or 6U1A21A (the lot number was written messily) expiry: unknown) dose was not reported, frequency time 1 total administered on 31-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On an unspecified date of FEB-2021, patient had COVID-19 antibody test, which was positive. On 01-APR-2021, the patient experienced pain in entire left arm from shoulder to the elbow (entire left arm from shoulder to the elbow on the left side hurt). On 07-SEP-2021, the patient had COVID-19 antibody test, which was negative (confirmed immunological vaccine failure).  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from entire left arm from shoulder to the elbow on the left side hurt on 01-MAY-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority:90000194167; Sender's Comments: V0: 20210940935-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
3/26/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  Dizziness and clammy following injection.   Assessment : Time of assessmen Alert and oriented. 1430    Actions taken: VS taken at 1430 BP- 149/97. P- 115, O2 sats- 100%, water given, recheck VS at 1436, BP- 112/70, P- 66,          Medications administered: No medication administered.   Disposition:The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/26/2021  2:32 PM
A report has been received from a Health Professional concerning an 8 year old, Female subject, who had been receiving nasal FLUMIST. FLUMIST started on 15-Jan-2014. We inadvertently gave expired FLUMIST. It was reported that the patient was administered expired FLUMIST on 15-Jan-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious by the reporter. Corrected report 01-Apr-2014: Positive dechallenge positive rechallenge information corrected. Initial received date and reporting clock start date and form completed date changed to 03-Feb-2014.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. An elderly patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: PARALYSIS (medically significant), outcome "unknown", described as ""an hour of paralysis""; CHILLS (non-serious), outcome "unknown"; TREMOR (non-serious), outcome "unknown", described as "flailing of arms and legs for about an hour". Reporter meet the criteria for a 2nd booster - I'm over 80, but I'm concerned about whether or not that might lead to an even more permanent result such as permanent paralysis. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Should've received Bexsero, gave Trumenba; Incomplete course of vaccination; This case was reported by a other health professional via other manufacturer and described the occurrence of interchange of vaccine products in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   Previously administered products included Bexsero (1st dose received in January 2021).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 27th January 2022, the patient received TRUMENBA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products and incomplete course of vaccination. On an unknown date, the outcome of the interchange of vaccine products and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not applicable. The patient should receive his 2nd dose 1 month after 2nd dose, however he never came back. Till the timeof reporting, the patient did not receive 2nd dose of bexsero which led to incomplete course of vaccination. The day before reporting, the patient was administered Trumenba which led to interchange of vaccine products. The caller need information if patient 2nd dose of Trumenba or no further doses required as patient received 2 different product. The sufficient data not available regarding interchangibility. The 2 Men B vaccines were not iterchangable, the same vaccine must be used for all doses in series. The minimal interval between 2 doses of Men B was 4 weeks.
Per patient's mother: excessive sleepiness for 1 week after vaccines - slept x5 hrs after vaccines & took 10 minutes to arouse, was fussy, limp, pale, lethargic x1-2 days.  Had vomiting & diarrhea intermittently x3 days.  Fever 5/5 - 5/6/08.
2nd day after 2nd dose - Rash all over back, torso sides, legs, one arm  & chin - started steroids on 5/26/2021
Started within one hour of vaccine administration - redness at injection site three inches wide almost down to elbow. Some itching.
Initial report was received from a health care professional on 16 September 2010. A female patient (age not reported) with an unknown past medical history, had received an intramuscular left deltoid injection of ADACEL, lot number C3488AA on 13 August 2010 and approximately six hours later, experienced a severe headache, temperature of 100.9, lethargy, dizziness, nausea, weakness, blurred vision and loss of sensation at vaccine injection site. No additional information was available at the time of this report. The patient's outcome was unknown. Documents held by sender: none.
Pt received MMR and PPD on 5/15/99. Her mother reported onset of symptoms about 3 weeks later. Her head was floppy, bobbing her head on her shoulder, decreased eye contact and squirming. She has been evaluated by a neurologist and dx is "encephalopathy" and autism.
COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on 09Mar2021 at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported after 2 days on 11Mar2021 patient was tested positive for COVID. She was in ICU for 3 weeks then in a rehabilitation for another 3 weeks. Patient wanted to know what to do on her 2nd dose. She was asking whether she needs to start over again on the 1st dose or was there enough antibody since she tested positive. The outcome of the event was unknown.
She got her vaccine, she had no reactions with them.  She woke up with rashes all over her body.  She took pictures of it as she thought it was an allergy.  She has raised rashes on all parts of her body, arms, legs, back, buttocks, chest, which starts with a burning sensation and knew that in any moment that it was going to erupt.  If she leaned on the spot and had the burning sensation and then would have raised rashes.  She would scratch in her sleep and that would make it worse.  She was trying to treat with home remedies, creams and so much and was taking showers, people were noticing if she was at a store as it was getting really bad.  After 2 weeks of not sleeping she made an appointment with her allergist but he retired so had to see a new one and had to wait 6 weeks.  She saw the new doctor and said he knew what it was but continued to examine her.  He did test her and she was having difficulty breathing at times as well.  She had a flare of her asthma due to the reaction during her sleep and if the rash got too bad.  He quickly did a breathing treatments as he could tell that she was having difficulty and he mentioned that he has been noticing 1-2 times a week that it was a reaction to the vaccine.  He did put her on medicine, 5 pills a day and new inhalers now and everything has improved and was able to sleep through the night that night and feels remarkably well.   She went to the allergist on 7/5/22, and has a FU on 7/28/22.
Itches slightly; Pale rash in a circle around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itches slightly) and VACCINATION SITE RASH (Pale rash in a circle around the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 10-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itches slightly) and VACCINATION SITE RASH (Pale rash in a circle around the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itches slightly) and VACCINATION SITE RASH (Pale rash in a circle around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Pt received vaccine and waited in observation . Left. Pt was in vehicle and driver brought her back to Gate 2 , said she felt dizzy and feeling faint. Pt was assessed did not want transfer. Refusal secured.
Bicep swelling, No redness, Mild Pain , Per Provider Ice , benedryl , return to clinic 4/2/21
Stronger pain in area of shot (compared to first dose) Soreness About 14-15 hours after the 2nd dose, I began feeling extremely fatigue. Also developed a slight chills feeling.  At the 21 hour mark, I was exhausted. Felt very weak and stared feeling a little warm. Around hour 22/23, body/bone aches developed.  By 24hrs after the 2nd vaccine, I took 800mg of ibuprofen (to help with the body aches and slight fever) and a Zyrtec for my allergies.  I'm awake and getting ready for work again (I worked through the symptoms yesterday, somehow) approx 34hrs after the 2nd dose. I feel "normal" considering my arm is still sore from the shot. But all other symptoms appear to have subsided; my only tiredness is from waking up early for work.
Approximately 2 days post vaccination developed small itchy bump on (L) arm and spread to (R) arm, back and both legs.
Soreness in arm x approximately 2 months post injection. Denies fever, swelling. Did not seek medical attention. Sx resolved on their own without tx.
have shortness of breath when she gets up to do stuff; pain in her lower left back; bloated stomach; burping; not feeling up to par; if she turns her head gets dizzy; real tired; real nauseated; ended up throwing up; Chilly; head hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (have shortness of breath when she gets up to do stuff), BACK PAIN (pain in her lower left back), ABDOMINAL DISTENSION (bloated stomach), ERUCTATION (burping) and VACCINATION COMPLICATION (not feeling up to par) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TOCOPHEROL (VITAMIN E [TOCOPHEROL]), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR), METOPROLOL, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), GLIPIZIDE, ACETYLSALICYLIC ACID (ASPIRIN 81) and POTASSIUM for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced DYSPNOEA (have shortness of breath when she gets up to do stuff), BACK PAIN (pain in her lower left back), ABDOMINAL DISTENSION (bloated stomach), ERUCTATION (burping), VACCINATION COMPLICATION (not feeling up to par), DIZZINESS (if she turns her head gets dizzy), FATIGUE (real tired), NAUSEA (real nauseated), VOMITING (ended up throwing up), CHILLS (Chilly) and HEADACHE (head hurt a little). The patient was treated with NAPROXEN SODIUM (ALEVE) for Symptomatic treatment, at an unspecified dose and frequency and SIMETICONE (GAS X) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (have shortness of breath when she gets up to do stuff), BACK PAIN (pain in her lower left back), ABDOMINAL DISTENSION (bloated stomach), ERUCTATION (burping), VACCINATION COMPLICATION (not feeling up to par), DIZZINESS (if she turns her head gets dizzy), FATIGUE (real tired), NAUSEA (real nauseated), VOMITING (ended up throwing up), CHILLS (Chilly) and HEADACHE (head hurt a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications Vitamin E, Hyzaar, Metoprolol ER, Effexor XR, Glipizide, Aspirin 81mg, Potassium.
Had normal reactions after the vaccine - swelling, itching, redness, and a knot.  It seemed to go away over about 7 days following the shot.  On day 8, it was itchy.  Then, it felt that the knot had enlarged.  It became warm to touch and a little red (not much).  It is not painful like it was after the injection.  It has not resolved, but it just started yesterday.  It is less red today, but it is about the same.
Left arm numbness for 1 day. Shoulder pain for 2 days. Hips and both knees pain and difficulty walking days 4 through 11. Treatment: Motrin, rest, heat to joints.
Pt. called to report redness,inflammation, which is a half dollar size- at the site on her Right arm today  where her varicella vaccination was given on 9/29/22. She reports a slight fever and nausea this morning when she woke up. She reports she plans to take benadryl for the inflammation. Recommended Ice for the swelling and tylenol or ibuprofen for the discomfort. She denies any shortness of breath, dizziness. Gave her phone number, if the inflammation continues to increase or her symptoms worsen so she can be seen by a provider. Pt. verbalized understanding
Information has been received from a licensed practical nurse concerning a male with no medical history or drug allergy who on 15-JAN-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number not available). In January 2009, the patient developed shingles rash on the right side of his upper torso. It was noted that the patient did not have any pain associated with the rash. He did not perform lab diagnostics tests. Subsequently, the patient recovered on an unspecified date. The patient was seen at the practice for medical attention. Additional information has been requested.
Returned 90 mins post Td with mild swelling of left upper lip. No other unusual exposures. No history of edema. Given antihistamine (po) and corticosteroid (po). No reaction at injection site.
Patient was given the dose for 6-35 months instead of the dose for 3 years and older. No adverse reactions or symptoms have been reported.
Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications are provide. treatment to the events not reported. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: follow up information received on 26-may-2021, it does not contain any new information.
The patient fainted and had 2 series of convulsions lasting a total of 3 minutes also known as syncope
Patient received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVAA379A, expiry date 31st August 2021) for prophylaxis.   On 11th October 2021, the patient received Menveo. On 11th October 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The medical assistant reported that, the patient received expired dose of Menveo, which led to expired vaccine used. The reporter did not consent to follow up. This case was 1 of 8 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232197:Same reporter US-GLAXOSMITHKLINE-US2021232193:Same reporter US-GLAXOSMITHKLINE-US2021232200:Same reporter US-GLAXOSMITHKLINE-US2021232201:Same reporter US-GLAXOSMITHKLINE-US2021232202:Same reporter US-GLAXOSMITHKLINE-US2021232206:Same reporter US-GLAXOSMITHKLINE-US2021232194:Same reporter