chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer) from product quality group. The reporter is the patient. A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 47 years for COVID-19 immunization; BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Lot number: FE3590), in right arm for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Chronic neck pain" (unspecified if ongoing); "Chronic lower back pain" (unspecified if ongoing); "cervical disc replacement" (unspecified if ongoing); "overactive bladder" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Prednisone, reaction(s): "Known allergies: Prednisone"; Cymbalta, reaction(s): "Known allergies: CYMBALTA"; Wellbutrin, reaction(s): "Known allergies: Wellbutrin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (Dec2022) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (Dec2022) Negative; (Dec2022) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical information: It was reported that the patient had COVID-19 in 2022. The patient started PAXLOVID as COVID-19 treatment from 19Dec2022 until 23Dec2022. It was stated that the patient tested negative 2x on rapid tests following completed PAXLOVID course.
Left arm soreness, Chills since around 1:30pm on 12/28/2020, nausea around 4:00 am, low temp fever 99.1
This spontaneous report was received from a medical assistant and unspecified reporter refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 13-AUG-2018, the patient was vaccinated with improperly stored dose of Oka-Merck PROQUAD, lot # N034561, expiration date: 03-JUN-2019, (dose and route of administration were not provided) for prophylaxis (incorrect product storage). The vaccine was reconstituted with sterile diluent which was properly stored. The vaccine underwent a temperature excursion -14 to -10 degrees Celsius for 3 hours and 30 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006154: US-009507513-1809USA004439: US-009507513-1809USA004440: US-009507513-1809USA004441: US-009507513-1809USA004442: US-009507513-1809USA004444: US-009507513-1809USA004445: US-009507513-1809USA004446: US-009507513-1809USA004447: US-009507513-1809USA004448: US-009507513-1809USA004449.
At 5:00 AM Sunday morning, extreme pain, achy all over, headache, aching all the way down legs, back, neck.  Almost like having the COVID virus.  Rolled out of bed, could not stand up or hardly walk to the bathroom.  Felt very faint, had to hold onto wall.  Was very sweaty, running temperature, cold sweats.  Just kept getting worse and thought about going to the ER and then decided to put it off until talking to somebody.  Called 2-1-1 and the lady told her that it was part of the side-effects to it.  She told her to call her doctor, and they were not in on the weekend.  This morning, the doctor called and asked if she had Corona, his other doctor retired and got this one the first of January.  Took 3 months to recover from the COVID and was on antibiotics, and told her because he have antibodies.  Feeling better, still having some achiness.
Initial pain and swelling at injection site, within 24 hours of vaccine: upper arm swelling, redness, tender. Started on prednisone 40mg QD x 14 days, cephalexin 500mg Q 6hrs x 7 days, oral antihistamine, elevate affected extremity. Will follow up with provider in 5 days.
Chills, severe muscle aches, low grade fever, mild nausea for 28 hours starting at 9 Pm April 8
10-12 hrs p/shot pt feet turned purple; legs swelled up real bad, elbows had red patches; pt has a 1" hard knot on the rt thigh 1 wk later;
At about 10 pm or approximately 5 hours after receiving my shot I noticed a slightly elevated heart rate. My resting heart rate is normally in the high 40's bpm to about 55 bpm.  My heart rate  remained elevated (between about 75 bpm to the  low 90's bpm) until about 2 am the following morning when it returned to normal where it has since remained.  I have had no other symptoms.  (Pfizer-BioNTech Covid-19 Vaccine EAU) I should add that from about 6:30pm to 7:30 pm I had two glasses of white wine.  I know that alcohol can be a cause of an afib  occurrence.
Patient complained of intermittent numbing, tingling down right side of face, neck, shoulder, arm and hands.  Lasts a minute at a time about 8 times a day. Started 1 week after vaccination. Still symptomatic 1 month later. Referred patient to PCP for possible other causative agents.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 14Apr2021 as dose 2, single (Lot number: EW0169), in left arm and on 11Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Sep2022) Negative, notes: Tested negative on Wednesday, 07Sep; (09Sep2022) Positive, notes: tested positive on Friday, 09Sep. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: Patient was not taken any Other medication in 2weeks. No known allergies and Other medical history reported as None. Patient had rebound COVID-19 infection after taking Plaxovid. Day 0 was Thursday, 01Sep. Tested negative on Wednesday, 07Sep and tested positive on Friday, 09Sep.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
p/vax pt exp colic, frequent spitting up, rash, asthma, heart problems/disease, viral or bacterial infect, irritability, ear infect, sore throat, eczema, resp infect, v, T103, poor appetite, convuls w/fever, paralysis, MS, swollen lymph nod
Client present for #1 dose of COVID Pfizer vaccine only today. Client monitored for 15 minutes after receiving vaccines.   Client left medical facility with wife. At approximately 1044 client returns with wife. Wife states while driving away client started feeling light headed, and appeared to have passed out. Client and wife were near local nursing home. Wife states she checked clients B/P and HR, which were within normal limits. Wife states client was pale, and sweating profusely. Client does not report having symptoms of an allergic reaction. This nurse rechecked B/P and HR at 10:46. B/P 110/68, HR 50. Wife reports to this nurse that color has returned to clients face. Client reports to this nurse he is feeling better, but does plan to take remainder of day off of work. Wife to be home with client to monitor. This nurse recommended for client to stay at clinic for another 15 minutes for monitoring. Client wife states she feels comfortable at this time to take client home. This nurse recommends for client to seek medical attention if another episode occurs this far out from vaccination. Client voiced understanding and no other questions at this time.
Received first set of baby shots, left the pediatrician's office and went to store. Became very fussy. Then in the car on the way home became more fussy before falling asleep. When arrived home, the baby's skin looked off white and the lips were cold and dark colored and the baby was not arousable. Parents took the baby to the ER where they were unable to revive him and he was pronounced dead after about 45 minutes. The baby had previously been to the ER on 12/18/08 for small size and for congestion. Was put on weight gaining formula and given Albuterol breathing treatment and sent home. Autopsy was done and showed 3 healing rib fractures that were old and the pathologist stated the baby had chronic bronchitis, but the cause of death was undetermined.  2/25/09 Autopsy report state COD as sudden unexplaineed death in infant & manner of death as undetermined.   2/25/09 Received ER records of 12/18/2008. FINAL DX: URI w/tachypnea Records reveal patient experienced SOB, nasal congestion, loose stool x 2 days.  Seen in PCP office x 2 for same & sent to ER for eval.  Resp rate in ER 64, pulse ox 98%.  Remainder of exam WNL.  Tx w/nebs & resp rate returned to WNL.  2/27/09 Received vaccine records & PCP office records which reveal patient in good health on 1/12/2009.  3/9/09 Received ER medical records of 1/12/2009. FINAL DX: DOA Records reveal patient brought to ER by parent.  Patient gray, limp w/no pulse or respirations after having found unresponsive.  Resuscitation attempts failed
On March 5, 2022 woke with sore throat in am between 8:00-9:00AM. I had just got back from a trip overseas and they tested me the Wednesday 03/02/2022 and it was Neg. I took a home test 03/05/2022 and tested positive. I got worse over the next few days and got a fever, congestion, cough, and fatigued. I did go to an Urgent Care and did a remote visit on  03/21/2022 because my symptoms were manageable but my cough did not go away. I was prescribed Antibiotic ZPAK, Inhaler Albuterol, and Tessalon because the cough prevents me from being able to sleep at night. The inhaler made me cough more so I followed-up with my PCP 04/06/2022 who ordered a chest x-ray. He prescribed me more Tessalon and scheduled a follow up for 2-3 months.
Extreme fatigue, shortness of breath for 1 week. 4 weeks later dizziness and blacked out. Heart stopped and I received a pace maker.
Client stated that she was experiencing sudden headache, jittery, and slightly lightheaded.  She voiced that the feeling of getting lightheadedness was not unusual but the sudden headache was.  Pt was seen and assessed by EMT.  VS as followed BP 150/89, HR 76, O2 97.  Pt cleared by EMT to go home.
Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 52-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself /himself. The age at vaccination was not reported. The patient got his/her shingles vaccine and got a huge outbreak of shingles immediately after, that went right up to the side of his/her face and in his/her mouth and then cleared up. The follow up would not possible as contact information was not available. For 2nd shingles outbreak refer case US2021AMR205369, reported by same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205369:same report
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 01/23/21 and 02/13/2021. COVID + on 1/10/22. Presented to ED on 1/17/2022 with acute hypoxic respiratory failure 2/2 COVID-19 and needed 2L on admit. Presented with malaise and SOB x 1 week. Previously admitted on 1/10/22 and treated with Decadron. CXR showed worsening bilateral pulmonary opacities given Lasix and also received supplemental O2 via HFNC +NC. Code status changed to DNAR. Patient expired on 1/25/22
Presented to emergency department with increased fatigue, body aches, fever, chills, and difficulty breathing and was found to be COVID-19 positive. Was treated with supplemental oxygen and dexamethasone and was discharged.  Patient presented to the ED again following low pulse ox readings at home in the high 60s. Patient was found to by hypoxic and was admitted for further management. Patient is still currently admitted.
Patient arrived for second dose of COVID 7 days prior to appointment. The error was discovered when she contacted pharmacy at 12:31 pm on 6/13/21. She complained of feeling fluish, headache, nausea and vomiting x3 beginning about 12 am the day after the immunization. She was advised to take acetaminophen and to increase liquids, including Gatorade or Pedialyte. I attempted to contact her to inquire how she was feeling. On 6/14/21, I left 2 voice messages at 8:40am and 12:09pm and reached finally at 3:21pm on 5/15/21. All of her symptoms of illness had resolved and she was fine.
2 days after vaccination, developed diarrhea, mucosy, heme positive, then fever (102.5). All cultures negative. Lasted several weeks. Now on Neolate
My right eye in the lower lash area developed a pox type lesion and the cheek on that side felt numb and I could not fully close my right eye for about 30 hours.  Then it went away.
This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # K020216, expiration date 17-SEP-2016) (lot # L006546, expiration date 10-NOV-2016), (route, dose and dose number were unspecified). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
I've been having problems with the upper part of both my arms - right down to the muscle and joint. Any circular motion, lifting my arms, or moving my arms around is painful. It's difficult now to lift weights, weight train, or exercise with my arms.   I've been using ice packs, heat pads, Tylenol, and Motrin to deal with the pain.
Cellulitis of left upper arm, shot gave 9-4-12 reaction 9-11-12 (this is when pt came in to physician office) Tx with DECADRON 4 mg IM & Doxycycline 100mg po BID x 10 days.
Patient called approximately 30 minutes after vaccination reported throat tightness.  Advised caregiver with patient to take her directly to ER.
Admitted to hospital on 11/7/22 with a few days of respiratory illness symptoms. Tested positive for COVID on 11/8/22. Pt discharged on 11/13/22.
Rash break out and itching; rash break out and itching; This is a spontaneous report received from a contactable consumer (patient). A 92-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unknown) via unspecified route of administration in Jan2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. This was following the rash break out and itching he had experienced after getting the 1st dose of the vaccine. The patient also mentioned that his dermatologist had advised him not to take the 2nd dose as side effects after the 2nd dose may be more intense compared to that of the 1st dose. He would also like to confirm this information. The caller was calling about the covid vaccine. The caller had the first shot in January at his retirement home. 3 to 5 days after the vaccine the caller broke out into a rash. The caller then had itching all around his waist and back. When the caller went to the dermatologist, the doctor told the caller not to get the second dose. How safe was it with the one shot? Can the caller give it to his grand kids and his grandkids give it to him with just the one shot? Would it be safe to get the second shot? Is there any type of pre-testing or half shot that the caller can get. I have a question I had my 1st shot back in January and 5 days later I broke out into rash and had itching which lasted about 6 months and I am over it, but I am wondering was there a way of seeing, whether I could have the 2nd shot. The outcome of the events was unknown.  Follow-up attempts not completed. Information about lot/batch number cannot be obtained. No further information was expected.
Flu like symptoms- Fever 100-102, chills, sleeping 18+ hours a day
Started with fever, chills, nausea, sore throat 16 hours after second vaccine, which was expected.  Fevers have continued for 2 weeks, sore throat resulted in swollen lymph node that makes swallowing easy.
cannot lift injection arm; pain at injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of LIMB DISCOMFORT (cannot lift injection arm) and VACCINATION SITE PAIN (pain at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 042L20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, TRIAMTERENE, AMLODIPINE and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced LIMB DISCOMFORT (cannot lift injection arm) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, LIMB DISCOMFORT (cannot lift injection arm) and VACCINATION SITE PAIN (pain at injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No treatment information was provided.
Extreme Vomiting for 30 hours after his 4 month immunizations. Started 6 hours after administration and vomited over 15 times. The had 2-3 large liquid stools with no blood or mucus. Fever of 101 the first day and then resolved.
No additional AE reported; Nurse called to report "vaccine error." She stated 2 month old patient was administered PNEUMOVAX 23.; Patient was intended to receive PREVENAR 13; This spontaneous report has been received from a nurse referring a 9-week-old female patient.  The patient's pertinent medical history, previous drugs reactions or allergies and concomitant medications were not reported.  On 11-MAY-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at a dose of 0.5milliliter once, lot number U021995, expiration date: 13-JAN-2023, administered as prophylaxis (route and site of administration were not provided) ; the patient was intended to receive pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13) (product administered to patient of inappropriate age, wrong vaccine administered). No additional adverse event was reported.
This case was reported by a consumer via call center representative and described the occurrence of hives in a female patient who received SHINGRIX for prophylaxis. On 18th July 2018, the patient received the 1st dose of SHINGRIX. On 20th July 2018, 2 days after receiving SHINGRIX, the patient experienced hives. The patient was treated with prednisone. On an unknown date, the outcome of the hives was Not Recovered/Not Resolved. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in right arm. On 20th July 2018, Friday, the patient noticed hives on her right underarm. On Saturday morning (21st July 2018), the patient had hives under her left arm, in the afternoon, she had hives under both breasts and in the bikini line and in the evening the patient had hives on both upper arms and the front of both thighs. By Sunday afternoon (22nd July 2018), most hives had cleared up. On Monday night (23rd July 2018), and Tuesday morning (24th July 2018), the patient had huge hives on both inner thighs, both arms, and both arm pits. The patient saw the doctor Tuesday morning (24th July 2018) and got prednisone. The patient wanted to know, if she was allergic to so she need to know what the ingredients are.
She was very tired and was on the sofa all the time and didn't want to eat, and had a fever. After that on the following day I called the doctor, I thought she was a bit better and planned to take her to the doctor. As the day progressed she was getting better Mon/Tuesday. By Wednesday morning my other child started feeling ill, so I took them to the doctor and got her tested. Each child was sick for about 2 days, then I got COVID-19 and then my husband.
after receiving vax, after 24 hrs, started having itching in eyes, and on face. Face became very rough, and color of skin on face is changing darker and darker. symptoms are still increasing after 3 days later. Feel weak, do not feel feverish. Face is still dark, rough and itchy.
Fever, Headache , Conjunctivitis and Fatigue. Fever and conjunctivitis lasted for 2 days. Low grade headache and fatigue for 7 days lasted 2 days Treated with Advil 2 tablets twice daily for 3 days
Patient reports pain to injection site that insidiously has moved into shoulder/neck and radiates inferiorly from the injection site.
This case was reported by a healthcare professional and described the occurrence of Hepatitis B surface antigen positive in a subject of unspecified age and gender who was vaccinated with ENGERIX B, (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of ENGERIX B (unknown route and injection site). Less than one day after vaccination with ENGERIX B, the subject experienced Hepatitis B surface antigen positive. At the time of reporting, the outcome of the event was unspecified. No further information was available.
3 year old was given Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number PP9L5, expiry date 16th October 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was 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 provided as follows: The 3 years patient received Kinrix in right arm, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
A few hours after the vaccine, my hands began to itch tremendously which was followed by a rash starting on my hands and moved down my arms. Then, my hands began to swell and become very tight. The rash spread down my legs and onto my feet. I went to the emergency room and was given a Benadryl and a prescription for Prednisone. As of 1 day on the steroid, the rash seems to have returned, but not as severe.
Shiver, sweat , fatigue  Through the night while sleeping  Symptoms disappeared after waking up  No treatment needed