chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had malaise and then she started going through one of her cycles of lupus where she had headaches and dystonia in her shoulders and neck; a sinus infection; Gets nausea; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A 48-year-old female patient (consumer) received bnt162b2 (COMIRNATY, solution for injection, (Batch/Lot Number: Unknown) dose 1 via intramuscular route of administration on unspecified date as SINGLE DOSE for covid-19 immunization. The medical history included of lupus, cluster migraines, ADHD. Concomitant medication was not reported. Patient took medication for cluster migraines, Tylenol and naproxen. Patient got her first Pfizer covid vaccine and for 5 days after, had malaise and then she started going through one of her cycles of lupus where she had headaches and dystonia in her shoulders and neck and these symptoms will last for 15 days. The headache then turned into a sinus infection and as a result of all this, she missed her second dose.  Patient wanted to know if it's ok to take these medications because her headaches affect her ability to function daily. Patient had to delay her second dose of the vaccine because she was feeling unwell. Her doctor told her to schedule two weeks away which would be today but she was about to start a new medication for her ADHD and to do that she had to come off of her other one which is a stimulant. She did not want to start a new medication right now with the problems that might come up along with getting the second shot and any side effects that she might have. She was frozen, just not sure what to do. Patient heard if you only get one dose, it was 80% effective. Patient was concerned if she only gets one dose, she'll be prevented from flying or doing other things because having the vaccine might be required but she had missed the window for getting the second shot so she doesn't know what to do. Rescheduled 2nd dose due to not feeling well. Has mild case of Lupus. Gets headaches and nausea. Would like to take Tylenol or Advil before getting 2nd dose but was worried it might interfere with vaccine. The outcome of the events were unknown.  Information about lot/batch number has been requested.
Patient received 2nd shot and was standing nearby when she started feeling nauseous. She took a seat and started to become pale. She felt sick in her stomach and was responding to questions. Pharmacy staff gave her a bottle of water and bag to vomit in (but did not vomit). Staff also checked her blood pressure resulting in 109/68 HR 65. She felt better and left. Pharmacy staff called mom to follow up around 3:30pm. Mom said she was doing better, but feeling tired.
high fever 102, crying to the point that lost breath, unable to stand or crawl. Tylenol given. 12 hours later, vomiting and diarrhea began. By 03/23/05- still crying. When at DR office by 4:00PM Tests done, WBC, Culture. Fever was still at 102, given Pedialyte, took home and monitored constantly. Diarrhea and bronchitis began, still going on. Unconsolable crying for 5 days with increased fever.
Guillain Barre Syndrome - Ascending Paralysis and numbness - acute inflammatory demyelinating polyradiculopathy 10-14 days after receiving H1N1 Vaccine
Side effects started after 4 minutes of the shot. I started with nausea, followed by shortness of breathe as well as heart pacing at a faster rate. The feeling was uncomfortable, so I stood up to walk around. After 15 seconds, I felt very nauseous as weak. Hey went to sit back down, but felled while trying to sit. I was able to sit back up and started to shake/shiver and sweat heavily. This happen for over 15 minutes, than it felt as it was coming and going.(the side effects) for the next 40 minutes, I felt very weak and stiff in the left arm.  After another 20 minutes, I started to feel better/normal. My arm started to feel less stiff.  Waited another hour and half total before discharged from the clinic.
Patient got a booster dose from an expired vial; No Adverse Event; This spontaneous retrospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got a booster dose from an expired vial) and NO ADVERSE EVENT (No Adverse Event) in a 34-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 21-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got a booster dose from an expired vial) and NO ADVERSE EVENT (No Adverse Event). The delivery occurred  on 28-May-2021, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient got a booster dose from an expired vial) and NO ADVERSE EVENT (No Adverse Event) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There were 3 patients in total. This case pertained to patient 1.  Patient mentioned that they (patient 1,2 and 3) got all the doses on the left arm, and did not take any medication regularly. Patient 1 was pregnant at the time of first and second inoculation and the delivery date was 28-May-2021.  1 vial, carried 10 doses, originally, only 3 doses were administered from it. The vial was left to thaw straight from the freezer right before being used.  No concomitant and treatment medication were provided COMPANY COMMENT: This is a case of expired vaccine used for this 34-year-old female patient who was approximately 5 months post-partum with no reported associated adverse event. The vaccine dose was a booster third dose administered approximately 10 months after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-360752 (Patient Link).; Sender's Comments: This is a case of expired vaccine used for this 34-year-old female patient who was approximately 5 months post-partum with no reported associated adverse event. The vaccine dose was a booster third dose administered approximately 10 months after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.
I could not use my arm for 1 1/2 days. It hurt so badly. My husband had to help me get undressed. I had to take off work. It took over a month to get where it wasn't hurting. This was the shingles shot.  Now I'm afraid to get the 2nd dose.
the luer-lock broke/literally broke off the syringe; The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM0169) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), described as "the luer-lock broke/literally broke off the syringe".  Additional information: The reporter was mixing up the Abrysvo and have mixed up quite of few of these already but this time the luer-lock broke. So the reporter could not use that dose, it is like literally broke off the syringe. Luer-lock that is the part that it goes on to the syringe to pull it back and to put a needle on it to inject it, the luer-lock broke.  Causality for "the luer-lock broke/literally broke off the syringe" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Woke up on the 8th day after shot, right arm muscle was swollen and rock hard, painful.  continued throughout the day, next few days it was sore but not hard anymore, and swelling went down.  No doctor care was needed.
pain; swelling; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: This case was reported through online chat. The age at vaccination was not reported. The patient experienced pain and swelling at the injection after receiving Shingrix. The reporter consented to follow up.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. Since 01-OCT-2014, the unspecified number of patients had been vaccinated with doses of GARDASIL (injection, lot#, dose, route and frequency were not provided), which had underwent supported and unsupported temperature excursions, (on unspecified dates of 2014). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Rash, hives itching experienced after vaccination with TWINRIX, Flu shot and Tdap.
Day one: 104°temperature, headache, chills, body aches.  Day two: 104° TEMPERATURE, headache. Chills , whole body aches and discomfort. Day 3: back to normal, all symptoms were gone.
Information has been received from a lawyer regarding a case in litigation concerning a 39 year old female with variety of ailments (general symptoms) who on unspecified date was vaccinated with a dose of RECOMBIVAX HB.  It was reported that subsequently the patient experienced autoimmune hepatitis.  The patient alleged that the hepatitis B vaccine had caused the autoimmune hepatitis.  The ruling was that "a preponderance of the evidence established that the hepatitis B virus does not cause autoimmune hepatitis."  The patient's physician withdrew the molecular mimicry theory primarily because no evidence showed a homology between parts of the hepatitis B vaccine and liver cells that were attacked by autoimmune hepatitis.  In follow up it was reported that patient had a variety of ailments that predated her hepatitis B vaccinations.  The reporter felt autoimmune hepatitis was not related to therapy with RECOMBIVAX HB.  This is one of several reports received from the same source.  No further information is available.
After 2 shots, pt complained of feeling "tired". This "feeling" lasted et mother reports had fever not measured via thermometer- 24 hours after injections, pt awoke with nasal congestion, swollen eyes et cough. Patient currently mouth breathing, sneezing with postnasal drip/eye tearing.
Intense myalgias, moderate headache, and severe fatigue starting 10 hours after immunization. Lasted for 24 hours and resolved without sequelae. Local injection site tenderness in the first 1-2 days was less severe than with the first immunization in this series.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a nurse regarding herself, a 49 year old female who inadvertently splashed Prevnar into her left eye on 2/1/2006. On 2/2/2006, the reporter developed red shot marks in the left eye. The patients concurrent illness included hypertension. Indication for Prevnar was not provided. Product was administered on 2/1/2006. Dose regimen was unknown dose ophthalmic. Concomitant therapy included Lopressor)metoprolol Tartrate). On 2/1/2006, when the nurse attempted to administer Prevnar, the needle dislodged and Prevnar splashed into the left eye (accidental exposure). On 2/2/2006 the reporter developed red shot marks in left eye ocular hyperemia. The nurse reported that her vision had not been affected. As of 2/3/2006, it was unknown if the reporter had recovered from the events. It has been determined that HQWYE708608FEB06, is a duplicate report of HQWYE708608FEB06. Therefore, the reports are being consolidated into HQWYE708608FEB06, which will remain the official case of record. No additional information was available at the time of this report.
Approximately 5 min after giving immunizations, pt became combative, c/o severe abd pain, throat pain. Patient was sweating and scratching skin. Mild exp. wheezes were noted, nasalcongestion also developed. Heart rate was 120bpm, BP was 115/60. Resp were rapid and shallow. Child was given 12.5mg oral benadryl, 40mg Solumedrol IM to L deltoid, .2mg epi SQ to L arm, one MA treatment of Xopenex 0.63. Child s/s did not improve so he was transferred to ER and admitted.  2/26/09 Received hospital medical records of 2/19-2/20/2009. FINAL DX: anaphylactic reaction to immunizations Records reveal patient treated w/steroids, nebs & antihistamines.  Improved & d/c to home w/PCP f/u.
received the 2nd dose 2 weeks after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose 2 weeks after the 1st dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose 2 weeks after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose 2 weeks after the 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took unknown drug for blood pressure as concomitant.  Patient had schedule procedure of colonoscopy for constipation. The constipation that patient had been experiencing since before patient received her doses of the Moderna COVID-19 vaccine.  No treatment medication was reported by the reporter.
stomach aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach aches) and HEADACHE (headaches) in a 74-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Loss of balance (loss of balance due to a concussion, asthma.), Concussion and Asthma.   On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach aches) and HEADACHE (headaches). At the time of the report, ABDOMINAL PAIN UPPER (stomach aches) and HEADACHE (headaches) had resolved. Not Provided      For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747591 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747591:Same patient (Different vaccine)
2 hours after receiving vaccine, Left arm became sore and felt hot at the injection site.  Symptoms progressed to where patient felt fevered, developed joint aches/pains and chills. No cough or upper respiratory symptoms.  Presented to ED achy all over, Left arm swollen and firm around injection site. No cough, no nausea and vomiting, no diarrhea. Diagnosed with acute cellulitis of left arm due to vaccine.
Pt said that the week after he got the shot the skin on his face slowly started to peel off and he got red spots on his face. I advised pt to be seen by MD to determine if was from the vaccine or other causes.
leg cramps; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation. The following information was reported: MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "unknown", described as "leg cramps". Additional information: The patient received the second dose of Pfizer COVID 19 vaccine about a week ago. After receiving the second dose of Pfizer COVID 19 vaccine, the patient started to have leg cramps at night and every other night.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two patients were administered MENQUADFI after not being suitable to use post temperature excursion with no reported adverse event; temperature excursion Negative 5.6 C  for 8 hours was caused by the door to the refrigerator being left open with no reported adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves unknown age and unknown gender two patients who were administered meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] after not being suitable to use post temperature excursion with no reported adverse event and temperature excursion negative 5.6 c for 8 hours was caused by the door to the refrigerator being left open with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date there was temperature excursion negative 5.6 c for 8 hours was caused by the door to the refrigerator being left open with no reported adverse event (product storage error) for meningococcal A-C-Y-W135 (T CONJ) vaccine.   On an unknown date, the patient received suspect meningococcal A-C-Y-W135 (T CONJ) vaccine at an unknown dose (lot number, expiry date: not reported) at an unknown administration site via unknown route for immunization.  On an unknown date the patient developed a non-serious two patients were administered menquadfi after not being suitable to use post temperature excursion with no reported adverse event (poor quality product administered) (same day latency).  Action taken: Not applicable.  Outcome: Unknown for both the events.   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 guidelines. 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.
Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient who experienced chills, fever and joint pain, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI977AB, expiry date: 09-Mar-2019 via unknown route in the left arm. On 26-Sep-2018, the patient developed a non-serious chills, fever and joint pain (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Other relevant tests included No lab data. Final diagnosis was joint pain, fever and chills. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for all the events. Additional information downloaded from database (level 2B) was received from nurse on 30-Oct-2018. Patient's demographics, lot no, therapy date and event onset date were updated in field and narrative and case became valid. List of documents held by sender: none.
Dosage Error, 2nd dose in primary series: Pfizer 5-11 formulation (orange cap) administered to a person 18 hears or older.  Patient notified and encouraged to be revaccinated.
Per patient the reaction started around 8pm. Ithching subsided around 11pm. Swelling was gone when patient awoke the next morning. Rash gone after next day.
pt recvd vax; pt devel candida infection following 1st vax; pt failed to seroconvert following 3rd dose of vax;
I wanted to let you know about a vaccine error that happened this last Saturday.  Order.  Patient was supposed to get moderna covid vaccine, but my immunizer that day reported they gave another person's flu vaccine, a fluarix.  I am sorry I do not recall that rx #.  Patient was fine at the time he left, but reported that this was his second flu shot for the year.  We was then given the correct vaccine.  I recorded what happened in his profile and faxed the information to the dr in case anything was to happen later.  Please let me know if there is anything else you need to know.
Lethargy, migraine duration 5 days. Slept for most of day for 3 days. Some chills, no fever.
This spontaneous report as received from a pharmacist refers to unknown number of patients of unknown age and demographics. Patient's current condition and medical history was not reported. On an unknown date (also reported as for the last several months), the patients were vaccinated with ZOSTAVAX subcutaneous injection (strength, dose, route and lot number not reported) which had undergone a supported temperature excursion). No concomitant medication was reported. On an unknown date, the patients experienced no adverse effects. There was no product quality complaint involved. Action taken and the outcome of the events were not provided. Causality was not reported. Additional information has been requested.
This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown age and gender. No pertinent medical history was reported. On 15-APR-2015, the patient was vaccinated with expired dose of PNEUMOVAX 23 (INJ N/A 10 VIALS OF 1) (lot # K005957 and expiration date 08-MAR-2015) 0.5 ml, intramuscular. No adverse effects reported. This is one of the two reports from the same source. Additional information has been requested.
Pt was very nervous and started crying right before vaccine. We stayed with pt and talked to her.  She said she felt better and had to go to restroom husband took her and they came right back saying she felt shortness of breath.  We called ems her O2 was 100% she said she just left hospital this morning she went in for anxiety.
Patient went limp in my brother arm, was very lethargic. He had trouble breathing for about 30 seconds and his face turned blue. We had to try and keep him up by patting his back, flicking his toes, and gently bouncing him. He didn't eat for 5 hours straight after getting the vaccines.