chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very tired; headache; chills; This is a spontaneous report from a contactable consumer or other non-healthcare professional.  A 43-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration in left arm on an unknown date in Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at Clinic/facility. Medical history included hypertension, high blood pressure, asthma, known allergies: Amoxicillin, Bactrim, Flagyl and lactose. The patient's concomitant medications were not reported. The patient did not receive any other vaccination in four weeks before covid vaccine administration. The patient did not have covid prior to vaccination and covid was not tested post vaccination. On an unknown date in Mar2021, after administration of first dose of vaccine, the patient experienced very tired, headache and chills. Outcome of the events very tired, headache and chills were reported as recovering at the time of this report.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Information has been received through the Merck pregnancy registry from a consumer concerning her 14 year old daughter with a sulfonamide allergy who on 27-JUL-2007 was vaccinated with the second dose of GARDASIL and then found out she was pregnant on 31-JUL-2007. There was no concomitant medication. As of 03-AUG-2007, the patient was approximately 13 weeks pregnant with an estimated delivery date of 07-FEB-2008. No medical attention was sought. Telephone follow-up information was received from a nurse who reported that the 14 year old patient did deliver her baby and that mom and baby were both doing well now. The mother experienced severe pre-eclampsia resulting in the baby being born early at 28 weeks "probably by c-section" weighing 836 grams in November 2007. The nurse indicated that the baby was on oxygen for some time while in the Neonatal Intensive Care Unit (NICU) post delivery and that the baby was normal with no congenital anomalies. This was the mother's first pregnancy. Upon internal review pre-eclampsia requiring baby to be born early at 28 weeks "probably by C-section" were determined to be an other important medical events. No further information is available.
Erythema, edema, warmth of L upper arm began on 6/29/10. Pt tx for cellulitis with Bactrim.
June 24th  I received the vaccine, June 25 a baseball sized "knot" formed under my right arm. On July 2nd i was rushed to the Emergency dept . with what was described as "vertigo". I returned to the hospital at my doctors behest because i was not able to use my right hand correctly and my speech was slurred. after a MRI was done  it was determined that i had had a stroke.
Patient came to ED on 10-4-2018. Treated for either local reaction vs cellulitis at site where vaccines were given on 10-1-2018. Put on Doxycycline 100mg BID, 20 caps. Also given Hydrocodone 5-325mg for pain. Next visit was today, 10-8-2018-continues with treatment. Arm still warm to touch and very tender. Some numbness in fingers.
Fatigue / tired; sleepy; This case was reported by a consumer via patient support programs and described the occurrence of fatigue in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (received 1st dose in January 2021 and experienced tiredness and sleepiness, refer case- US2021151991).   In June 2021, the patient received the 2nd dose of Shingrix. In June 2021, less than a month after receiving Shingrix, the patient experienced fatigue and sleepiness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fatigue was recovering/resolving and the outcome of the sleepiness was unknown.   It was unknown if the reporter considered the fatigue and sleepiness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient had Shingrix vaccine in June 2021 and experienced fatigue, felt very tired and sleepy. The batch number for Shingrix was unknown. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151991:1st dose
Patient still hospitalized at 10 days admission. Patient is a 64 y.o. female with history of oxygen dependent COPD, chronic pain syndrome on chronic opioids, depression with anxiety, and former tobacco use who presents to the ER with worsening shortness of breath with cough in setting of COVID-19 infection.  The patient lives at home with her daughter and grandson who tested positive for COVID on 12/21.  The patient developed symptoms shortly after in tested positive on 12/22.  She was fully vaccinated with Pfizer vaccine and booster on 10/27/2021.  Patient complains of fevers, chills, generalized weakness with fatigue, worsening cough and shortness of breath.  Patient reports she last had a short course of antibiotics about 1 month ago for bronchitis.  She does has significant chronic obstructive pulmonary disease, on 2 L nasal cannula O2 at baseline, and former tobacco use.  Patient reports chronic steroid use, typically on prednisone 7.5 mg daily, although patient self increased prednisone to 10 mg daily 3 days prior to arrival.  Patient also has chronic pain, follows with pain clinic, and takes methadone 10 mg 4 times daily as well as Norco 10 daily.   In the ER, patient remained afebrile, normotensive, borderline tachycardic, not tachypneic.  Patient did desat to 88% on her baseline 2 L nasal cannula, bumped up to 3 L. chest x-ray showed significant emphysema with superimposed multi focal faint opacities.  Labs unremarkable with normal renal function, no leukocytosis, normal procalcitonin.  Patient received Solu-Medrol and remdesivir in the ER.  The patient was admitted to Internal Medicine for further evaluation and treatment of acute on chronic hypoxic respiratory failure due to COVID-19 pneumonia.
Patient received Moderna Covid vaccine on 6/22/22 at facility.  She had her 15 month physical at facility and received a Pfizer Covid vaccine on 8/17/22.   Patient's condition is stable.
Patient received Bivalent Booster dose from vial that had "end of use date" that was expired by 13 days.  No untoward effects to patient.
pt had several myoclonic jerks & then on 5/18/99 had a gen febrile sz;5/19/99 had a gen non febrile sz; still waiting to see if sz will recur
Narrative: Patient is a 68 year old male for whom a ADR to the COVID 19 vaccine was documented in the patient's chart. Patient received a COVID vaccine from a non-primary care provider in Aug 2021. An ADR was documented in Nov 2021. Unsure if this ADR is for the first or second COVID vaccine.
NEUROPATHY; BURNING SENSATION ALL OVER THE ENTIRE BODY FOR 4 DAYS W/ FEVER
ROTATEQ, PEDV AX HIB, RECOMBIV AX HB, GARDASIL 9 and VAQTA that went out of range were potentially administered; No additional adverse effect reported; Information has been received from a nurse istant and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On unknown dates, the patient was potentially vaccinated with doses of the following vaccines that were out of range: hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # R028529 and expiration date of 09-JUN-2021, lot # T004378 and expiration date of 01-NOV-2022 and lot # R021372 and expiration date of 25-MAY-2021, hepatitis a vaccine, inactivated(VAQTA) lot # T020442 and expiration date of 26-JAN-2022 and lot # T014835 and expiration date of 17-JUL-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T001208 and expiration date of 09-JUN-2022 and lot # T020615 and expiration date of 13-MAR-2023, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 1621926 and expiration date of 28-NOV-2021 and lot # 1602284 and expiration date of 26-SEP-2021 (route of administration and anatomical location were not reported) and with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1676322 and expiration date of 21-APR-2021, lot # 1688822 and expiration date of 20-NOV-2021 and lot # 1691301 and expiration date of 12-DEC-2021 per oral route, all for prophylaxis, which were stored in the following ranges: 9 Celsius degrees to 25 Celsius degrees (8.53 Celsius degrees) for 15 minutes and 9 Celsius degrees to 25 Celsius degrees (11.6 Celsius degrees) for 45 minutes.  No previous temperature excursion was reported. No additional adverse effects were reported.  Digital data logger was involved.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2103USA005236: US-009507513-2103USA005237: US-009507513-2103USA005238: US-009507513-2103USA005239: US-009507513-2103USA005240: US-009507513-2103USA005241: US-009507513-2103USA005234: US-009507513-2103USA005233: US-009507513-2103USA005235:
Began with joint Stiffness which moved around to different joints, eventually becoming symmetrical affecting ankles, knees, elbows, hands with pain, stiffness, heaviness. Did not go to DR until worsened. Problem walking, stairs. Referred to rheumatologist who diagnosed autoimmune disorder, reactive arthritis. Ongoing managed with medications. 3/21/06 Received medical records from rheumatologist which revealed patient experienced dx: inflammatory reactive polyarthritis, allergic rhinitis, fever, chills, fatigue, pain of joints, edema, limited ROM, anemia, decreased hand grip. 3/21/06 Received medical records from rheumatologist which revealed patient received vax 2001 & presented in 2002 w/fatigue, fever, chills, night sweats, weight loss, sudden symmetrical continuous joint pain & stiffness which awakened her at night.  PMH: skin cancer, anemia & pneumonia.  DX: inflammatory reactive polyarthritis & allergic rhinitis.  Tx: steroids, arthrocentesis & added actonel & plaquenil.  3/31/06 Received medical records from PCP w/vax lot numbers.  No hx arthritix & no trauma.  Was not on any meds & had no allergies.  DX: arthralgias./ss. Follow up received 04/09/2007. I continue to need prescription medication to manage the joint stiffness.
gave patient immunization and about 5 minutes after administration patient began feeling light headed, dizzy, and clammy. Had patient sit with head between legs and sip water. After about 10 minutes patient felt better. had them sit for an additional 10 minutes or so and afterwards patient said they felt fine.
arm pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th May 2021, the patient received the 1st dose of Shingrix (intramuscular). On 10th May 2021, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient received his 1st dose of Shingrix vaccine on 10th May 2021 and was still experiencing arm pain at the injection site. The reporter consented  to follow up. No further information was reported.
Complained of flu like symptoms days after receiving 1st dose of Trumenba; Headache; Sore at injection site; Dizziness; Generalized pain; This is a spontaneous report from a non-contactable consumer via a Pfizer Sales Representative. This consumer reported similar events for four patients. This is the second of four reports.  A patient of unspecified age and gender received the first dose of meningococcal group b rlp2086 (TRUMENBA; lot number AL8468) via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient complained of flu like symptoms days after receiving 1st dose of meningococcal group b rlp2086, headache, sore at injection site, dizziness and generalized pain. The outcome of the events was unknown. Office said they have seen this in the past where every patient who got a TRUMENBA complained of side effects, then that lot number finished and they used another lot number and they heard anything from patients about side effects. They were starting to hear more complaints and wonder if it was the vaccines associated with specific lot numbers.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019271974 same reporter, different patient.
A nurse did a double dose (1ml) in error; A spontaneous report was received from a nurse concerning a 81-year-old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and a nurse did a double dose (1ml) in error.   The patient's medical history was not provided.  No concomitant medications were provided.  On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 025L20A) for prophylaxis of COVID-19 infection.   On 06 Jan 2021, a nurse gave the patient a double dose (1 ml) of the vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, a nurse did a double dose (1ml) in error, was considered resolved on 06 Jan 2021.; Reporter's Comments: This report refers to a case of a 81-year-old female patient who experienced non-serious event of nurse did a double dose (1ml) in error (Inappropriate dose of vaccine administered for mRNA-1273 (lot # 025L20A, Exp date-unknown). There were no reported AEs associated with the event of Inappropriate dose of vaccine administered.
It seemed to work it's way through my body, Effecting mobility, shoulder, hands, knees, hips and feet. mostly on the right side of my body. 6 months of physical therapy. Just know getting my strength back. Pfizer vaccine.
HISTORY OF EVENT: Patient is experiencing numbness and tingling in his fingers and toes upon waking this morning.  He received his flu shot yesterday in his left leg.  He describes it as tickling around his fingertips, and feels like there is dirt under his fingernails; he reports a similar sensation in his feet.  He has a low-grade fever of 100.0, a tummy ache, and states that his chest and throat area might be a little sore.  Patient's mother is a nurse and reports his heart rate to be around 110.  Overall Patient is eating, sleeping, and voiding well and seems to be himself.  Denies shortness of breath, coughing, wheezing, dizziness, lightheadedness, loss of appetite, fatigue, and syncopal episodes.   TREATMENT:  Patient is a 6 y.o. male presenting via video visit with his mother today for evaluation for numbness and tingling in his hands and feet following flu immunization.  Family counseled that this is likely a systemic reaction with fever, with a hyperventilation and/or anxiety component.  Instructed parents to provide Patient with a paper bag, and have him breathe in and out slowly, to rebreathe his air and normalize his carbon dioxide levels.  He may continue to repeat this maneuver if the symptoms should continue throughout the day.  Following initial breathing exercise, Patient's numbness and tingling resolved.  Parents advised to keep patient home from school in the event that repeated breathing exercises are needed today.  In the event that numbness and tingling do not resolve with breathing exercise, family instructed to bring Patient into clinic for further evaluation; additional workup may include evaluation of electrolyte imbalances.  Case discussed with Dr. who was in agreement and provided breathing exercise instruction.     Reviewed symptomatic care, signs and symptoms of danger, and reasons to seek care emergently or return for evaluation.  If there are any further concerns, they may contact the clinic. Will report vaccine reaction to VAERS.
Case number PHEH2015US026971, is a spontaneous report initially  received from a nurse on 22 Dec 2015. This report refers to a 22 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 19 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were no problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Breakthrough case admission after 2 vaccines moderna 1/27/21 lot#029L20A;  Moderna 12/1/21 lot# 034F21A
My resting heart rate after the vaccine is 153 before I did not have any heart problems. In a month I have lost 12 ponds!constant headache  My chest Is heavy and sore so is my stomach I got my second dose yesterday and I constantly feel dizzy and unable to be productive.
Shortly after receiving first vaccine, patient was waiting in line to schedule second dose.  During this time, became syncopal and fell.  Transported to urgent care for monitoring, and discharged in stable condition.  Provider conclusion is that patient experienced a vasovagal event secondary to injection.  Vaccine itself does not appear to have any correlation to the event, but given that patient was transferred to a higher level of care, will submit a VAERS report.
Pt recvd 1st dose of Recomb on 7FEB91 & exp urticaria, nausea, arthralgia & generalized myalgia; Pt hospitalized & tx Adrenalin & IV fluids;
Received Pfizer COVID-19 Vaccine in right arm. 1 hr later noted left sided facial tingling lasting 48 hrs.
couldn't sleep and felt like a zombie. It made her weird; not knowing what caused the cough has taken her anxiety to another level; dry cough that feels like a tickle in her throat; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough that feels like a tickle in her throat), INSOMNIA (couldn't sleep and felt like a zombie. It made her weird) and ANXIETY (not knowing what caused the cough has taken her anxiety to another level) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Drug-induced cough. Concurrent medical conditions included Granuloma (Granuloma in lungs). Concomitant products included GUAIFENESIN for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced COUGH (dry cough that feels like a tickle in her throat). On an unknown date, the patient experienced INSOMNIA (couldn't sleep and felt like a zombie. It made her weird) and ANXIETY (not knowing what caused the cough has taken her anxiety to another level). At the time of the report, COUGH (dry cough that feels like a tickle in her throat), INSOMNIA (couldn't sleep and felt like a zombie. It made her weird) and ANXIETY (not knowing what caused the cough has taken her anxiety to another level) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported on 23Feb2021 that she received the first dose of the Moderna vaccine on 17Feb2021 in her arm. On 20Feb2021 she developed a dry cough that felt like a tickle in her throat. She got the vaccine at the same time that she started a new medication, Guanfacine, and doesn't know if the cough is caused by the new medication, side effects from the vaccine, allergies or that she has developed COVID. She stopped taking the Guanfacine because she couldn't sleep and felt like a zombie. It made her weird. The not knowing what caused the cough has taken her anxiety to another level. She has a history of developing a cough with new medications and does have granulomas in her lungs.
I woke up at approximately 11:45pm on 9/28/22 with an extremely fast heartbeat over 150 beats per minute. I was very lightheaded. I called 911 - paramedics confirmed that I was in AFib and I was transported by ambulance to Hospital where I was told I was in AFib with RVR.  After a short period of time in the ER, I was sedated and had a successful cardioversion and was discharged shortly thereafter. I informed the ER doctors that I had had the Covid-19 Pfizer Bi-valent booster just 36 hours prior to the onset of Afib with RVR.
father had a Tia several weeks after receiving the COVID vaccine - Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 91-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "He has blood pressure issues" (unspecified if ongoing), notes: Optional Information: He has blood pressure issues and meds. He is 91. The patient took concomitant medications. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown", described as "father had a Tia several weeks after receiving the COVID vaccine - Pfizer".  Clinical information: The patient's father had a Tia several weeks after receiving the COVID vaccine - Pfizer. He had blood pressure issues and meds. He was 91. The event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On  12-28-2020, I felt pretty fatigued and developed a fever throughout the following day.  I lost most of my appetite and had quite a bit of diarrhea for about 24  hours.  I went to the ER urgent care on 12-29-2020 in the evening. I was in the ER room for that evening then I was discharged.
Patient presented to the hospital 7/18/21  and admitted for one night for COVID-19 symptoms and cellulitis of the right foot.  Patient readmitted 8/3/21.