chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received PREVNAR 13, via an unspecified route of administration in 2018 at single dose for pneumococcal pneumonia. One year ago, the patient got both a pneumonia shot and a shingles shot. The patient thought the old pneumonia shot she got was "plain" PREVNAR and the one she received a year ago might have been PREVNAR 13. She was not sure exactly which one it was. The patient medical history and concomitant medications were not reported. On 13Jan2018, the patient woke up with a scratchy throat. Every day that went by, she felt worse. On an unknown date (reported as on Wed the 16th), she started to run a 100- 101 degree fever. By Thursday, she was really sick and did an online chat with a doctor. Her temperature was 104 at that time. She was sick to stomach, coughing, and had chills. It was like being in shock. It was found the patient had bacterial pneumonia in the upper lobe of the right lung. She was pretty dehydrated and was given an IV bag of an antibiotic and an oral antibiotic. The patient felt slow, with no energy. She was exhausted and wiped out. She didn't have issues with breathing. She thought she might die from this. To go from Sunday to Thursday to feel progressively worse, she thought it was an acute illness. She had a scratchy throat, problems with hearing due to congestion, and nausea. Part of the nausea was because of the cough. She was gagging. She was afraid she would be contagious, so she drove herself to urgent care even though she was so weak at that point. She couldn't eat anything. All she did was lying in bed. She got pneumonia and it was devastating. She felt it would have been worse if not having got the pneumonia shot and it could have been deadly. Treatment was received for the events bacterial pneumonia and dehydrated. The outcome of the event scratchy throat was not recovered and for the other events was unknown. The information on batch/ lot number has been requested.
Patient falsified DOB when registering for vaccination, stating the minor was 9/14/2016. Guardian consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB is 9/14/2017 which made the vaccine a contraindication.  No known adverse reactions noted.
07/25 Full body rash; itchy and burning. 07/26 Gout-like pain left big toe (no prior gout pain). Unable to bear weight on foot. 07/27 Meet with doctor and was prescribed 20 mg Prednisone and 20 mg Famotidine 07/31 Swelling and joint pain in fingers; moderate pain and still experiencing rash varying in intensity 08/03 Unable to bend left pinky due to swelling 08/04 Joint pain gets worse in fingers and now wrist 08/05 Meet with  at doctor 2pm for ongoing symptoms. Prescribed 40 mg Prednisone and continue 20 mg Famotidine. Ordered lab work. Pain and sweeping turned severe around 9pm. Unable to gripe or move wrist without extreme pain. Pain continues up to left shoulder and right elbow. 08/06 12:30AM Emergency Room visit for lightheadedness and nausea due to pain. Given Deposit-Medrol.
PATIENT REPORTED BACK TO VACCIEN CLINIC WITHIN 20 MINUTES WITH NUMBNESS IN THE LEFT ARM (SIDE USED FOR VACCCIANTION), ITCHING, UTICARIA, AND BURNING SENSATION.  PATIENT ESCORTED TO ER TO BE SEEN.
Per mother-red, egg size mark on arm (Lt deltoid area) starting the morning after her injections. Body ache and low grade fever (100-104) Mom started Benadry and Ibuprofen and ice to local area. Redness increased to nearly cover upper arm. See in ER 4 days after injection 2-4 hr sudden increased in redness. Started on Acithromycin and TMP/Sulfa-Today c/o abd discomfort and nausea. Still has body aches, redness decreasing in size.
59 year old female started shaking after receiving vaccine. On site Ems responded. Vitals BP 160/98  HR 76  100% O2 on room air She had taken her medications this morning. She recovered and went home.
With the second shot, he developed covid toe; He had a rash and swelling on his feet; He had a rash and swelling on his feet; very worn down for about three days after each shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (With the second shot, he developed covid toe), PERIPHERAL SWELLING (He had a rash and swelling on his feet), RASH (He had a rash and swelling on his feet) and FATIGUE (very worn down for about three days after each shot) in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Lyme's disease and Crohn's disease.   In June 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (With the second shot, he developed covid toe), PERIPHERAL SWELLING (He had a rash and swelling on his feet), RASH (He had a rash and swelling on his feet) and FATIGUE (very worn down for about three days after each shot). At the time of the report, IMMUNISATION REACTION (With the second shot, he developed covid toe) outcome was unknown and PERIPHERAL SWELLING (He had a rash and swelling on his feet), RASH (He had a rash and swelling on his feet) and FATIGUE (very worn down for about three days after each shot) had resolved.            No concomitant medication was reported.  Patient's wife reported that the patient received three Moderna COVID-19 vaccines. After the second shot, he developed 'covid toe' where he had a rash and swelling on his feet. He also developed this 'covid toe' after the booster shot but it was not as severe. The patient was also very worn down for about 3 days after each shot.  No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was linked to MOD-2022-616834 (Patient Link).
Severe arm pain and flu like symptoms the next day,  but 5 days later knee and hand joint pain and swelling, and facial excema. Those symptoms lasted 6 weeks and were severe enough to affect my daily life and cause me to limp. Went away without Treatment after 6 weeks
burning in back of neck (rt side), swelling-pain, redness, warm to touch,  hardness, chills, poss fever, nausea, h/a, pain started immediately;
Had immunization on 01/10/2005 11:30AM. Saw in Dr office 1/13/05 with c/o running temp up to 103.6 since. 1/10/05. Diagnosed on 1/13/05 with tonsillitis and RAD and placed on antibiotic. (3 reaction to immunizations)
Fever, cough, nasal congestion, rash-morbilliform to abdomen / trunk - ? legs and face  - blanchable morbilliform rash - transient vs measles, sub-clinical s/p mmr - 10 days ago.
HCP calling to report administration of expired MMR-II vaccine and requesting information regarding stability after expiration.; No additional AE; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) subcutaneous injection, 0.5 milliliter/once, lot #U006486, expiration date: 26-FEB-2023, administered for prophylaxis (anatomical location, and route of administration were not provided) (expired product administered). The reporter requested information regarding stability after expiration. It was reported that there were no temperature excursions to product.  There were no adverse events reported (no adverse event).
Two day of fever followed by measles rash. Red 3-4 mm palpable rash without blisters or excoriations on face, chest, and arms scattered.
4/13 coworker received text message from mother of pt who reports that began experiencing "hives" after taking the Janssen vaccine; started on abd then spread to extremeties, back and neck Phone call to (nurse at the jail) who states she is aware of the hives and has pictures, no c/o respiratory difficulties. They have administered topical antifungal and tx for scabies thinking maybe it was related to a new blanket. Advised  that due to the new reports regarding Janssen, it would be advised to have him evaluated by a physician.  agreed, she will reach out to her provider for guidance.  Report from mom that was taken to the ER and given a topical steroid cream only.
arm pain; Difficulty breathing; sun sensitivity with blotches form on her stomach red blotches; sun sensitivity with blotches form on her stomach red blotches; extremely tired; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A 67-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, administered in left arm, on 06Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took ZYRTEC (cetirizine hydrochloride) (lot number and expiry date were unknown) for allergy and had blotches on stomach occasionally when patient took Zyrtec years ago (start date was unknown and stopped taking it 10 to 15 years ago). On 07Mar2021, the patient experienced sun sensitivity with blotches form on her stomach red blotches, extremely tired and difficulty breathing. On 07Mar2021 at 02.00, the patient experienced arm pain. The patient reported that after receiving the vaccine she felt extremely tired and had a sun reaction reporting that while laying in the sun she started seeing blotches form on her stomach red blotches. She did not normally react to the sun. She had blotches on her stomach occasionally when she took Zyrtec years ago. Today (08Mar2021) while sitting in the sun she did not blotch but she got so tired. She had difficulty breathing when she walked around too much. The arm pain woke her at 2.00 and it was throbbing. She also reported that when she started feeling tired she went inside to lay down and after resting she felt better and the blotching went away. The patient was asking if this was a common reaction and if these reactions were heard by Pfizer. The patient also asking that should she be concerned. The outcome of the event extremely tired, arm pain and difficulty breathing were recovering. The outcome of the event sun sensitivity with blotches on her stomach was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Patient developed a generalized, erythematous, maculopapular rash on 9/27.  She was seen in our office on 9/28.  She was slightly fussy, though afebrile.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 05-APR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
Injection site arm very swollen, red and painful. Pt contacted MD and was told how to care for it. Currently in this state.
Hives, i..e  chronic itching all over body, i..e hands nose, lips, insect bite sores, etc.
VERBAL CONSENT OBTAINED, MONITORED FOR 15 MINPER POLICY, AT THE 15 MIN MARK PATIENT COMPLAINED OF  MY BODY FEELS IMMEDIATELY TIRED AND WARM AN HEAVYBP 126/78 HR 74 POX 99 RA, KEPT FOR ANOTHER 15 MIN TO  MONITOR
Fever of 101, chills, severe body aches, mild headache,  nausea, pain at injection site
pink and red rash on upper left arm (lighter at the top) appeared morning of Feb.5, no itching/pain, no fever rash began fading from top to bottom within 24 hours
Information has been received from a physician concerning a 5 year old female who on  17-AUG-2007 was vaccinated with zoster vaccine live (Oka/Merck). There was no adverse event reported. In follow-up, the physician noted that the patient was in for a routine varicella virus vaccine live (Oka/Merck) booster. The employee who gave the vaccine was not permanent staff but medical assistant from OB/GYN who was helping out. The administering health professional stated that the vaccines were both in the freezer in their own boxes. She stated that they both stated zoster and the boxes did not state adult or pediatric use. The box in front was zoster vaccine live (Oka/Merck) and she pulled that one out and administered it. The physician noted that the patient did not experience any untoward effect. No further information is expected.
Vertigo began 12 hours following. Has persisted with headache and dizziness with periods of shortness of breath since. Worsened after second dose. Constant disoriented sensation.  I am now in physical therapy and diagnosed with vestibular hypofunction and trying to regain my quality of life.
Chronic hives recurrence. Started June , occurred everyday since. Last affected in June 2016 thru Dec 2017, no known cause.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and PEDVAXHIB (Lot number, expiry date, route an dose were not reported). Certified Medical assistant reported that both vaccines were exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated other 104 children received GARDASIL and other 18 children received PEDBAXHIB. Follow up information has been received from the certified medical assistant regarding a 17 years old, female patient with no pertinent medical history reported. On 04-SEP-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). Concomitant therapies include MENACTRA (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
The vaccine was administered to the patient with a subq needle; A spontaneous report was received from a pharmacist concerning 65-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) administered with a 5/8-inch (subcutaneous) needle.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot#026L20A) for prophylaxis of COVID-19 infection.   On an unknown date, the patient was administered a vaccine using a 5/8-inch (subcutaneous) needle. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, vaccine administered with a 5/8-inch (subcutaneous) needle, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of Product administration error (administered with a 5/8-inch needle) for mRNA-1273, lot # 026L20A.  There were no reported AEs associated with this case of Product administration error. The reported event is unlisted and company causality was assessed s not applicable.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 28-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# F63180), at the age of 28, in left arm, on Aug 15, 2021, at 15:00, single dose, for COVID-19 immunisation. Medical history included diagnosed with COVID-19, start date: Mar 2021 (unspecified if ongoing), notes: diagnosed in March. No concomitant medications. The patient experienced menstrual disorder (7 days after vaccination, started period again; it lasted 5 days), onset Aug 22, 2021, with outcome of not recovered. No therapeutic measures taken as a result of menstrual disorder. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient was not on any birth control or hormones. Prior to vaccination, patient diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. Follow-up attempts completed. No further information expected.
Information has been received from a nurse (L.P.N), for GARDASIL, a Pregnancy Registry product, concerning a 15 year old white female with drug allergy to ZITHROMAX and amoxicillin and no history of pregnancy who on 08-AUG-2011 was vaccinated IM with the first dose of GARDASIL(Lot # 666596/0766Z). On 26-OCT-2011 the patient was vaccinated IM with the second dose of GARDASIL (Lot # 670048/0963AA). Concomitant therapy included prenatal vitamins, "PHENERGAN" and albuterol. On 11-NOV_2011 the patient presented to the office and was determined to be "11 weeks pregnant by HCG test and ultrasound (performed on 15-NOV-2011)". Her LMP was 24-AUG-2011 (reported as September 2011) and EDD was 30-MAY-2012. Follow up information received. The reporter's office was called at, for the pregnancy outcome information but they had no additional information to provide. The pregnancy outcome and case was to be considered lost to follow up. All telephone attempts to obtain follow up information had been unsuccessful. Additional information is not expected.
This week, August 14ish, my left arm became unusable...the muscles over my shoulder hurt if I tried to lift the arm, and the pain kept me from sleeping. Aspirin allows me to forget, but since that's the injection arm, I thought it might be important to report.  So, the pain began on Saturday...still there Sunday...seemed to disappear on Monday...now it's back and worse: I'm planning on using a sling. The same muscles are active when I sweep the deck, etc...and this may have nothing to do with the shots BUT maybe it does.
Patient received Johnson and Johnson COVID vaccine, patient began having lightheadedness and vomiting, famotidine 20mg provided, short period after patient began vomiting again so loratadine and famotidine were both given. A short period after patient began feeling lightheaded and nauseous again so Epi-pen was given. patient was monitored for another hour and a half and began feeling lightheaded and like her heart was racing. at this time the provider called report to the ED and patient was taken to ED via wheelchair for further monitoring.
delayed transit of Fluzone HD was administered, no AE; delayed transit of Fluzone HD was administered, no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from Nurse.  This case involves a 76 years old male patient who was vaccinated with dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot: UJ283AB, expiry date: 29-May-2020), via intramuscular route in the right arm accidentally, on 14-Oct-2019  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was a case of incorrect product storage and product shipment delay due product was to be delivered on 10Oct2019 and was not received until 14Oct2019.  At the time of reporting, the patient had 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 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.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Severe, Additional Details: After administration, patient was flushed red in the face and her friend (who was translating) said that the patient's throat was closing up and she was having difficulty breathing. The patient fell off the chair and I instructed the friend to elevate her head from the ground to keep the airway open. Patient was screaming and complained of pain radiating from the back of the neck to the lower back. Epipen injection was administered, and 911 was called. Patient could breathe and no longer flushed
This case was reported by a pharmacist and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4, 7 or 8 November 2011 the subject received a dose of FLULAVAL (.5 unknown route, unknown). On an unknown date in November 2011, several hours after vaccination with FLULAVAL, the subject experienced injection site redness, swelling injection site and injection site pruritus. According to the pharmacist, the hospital had a flu clinic between 04 November through 08 November 2011. Approximately 40 subjects were administered FLULAVAL from the same lot. Of the 40 subjects, five subjects experienced injection site redness, swelling and pruritus. This case was associated with a pharmaceutical product complaint. The pharmacist was suspecting a questionable batch of vaccine. She noted that a sister site had administered FLULAVAL with a different lot number and had no adverse events reported. At the time of reporting the outcome of the event was unspecified. This is two of five cases. See cases A0952517A, A0952521A, A0952522A and A0952523A for information regarding the other cases.
Mom called our office later in the day today to report that pt has hives. The  only thing mom reported that is different today is that he received his 4th-DTaP.
Employee reports moderate to severe pain over distal deltoid area right arm that is interfering with range of motion.  No noted swelling, erythema, or increased heat on palpation.  Painful area approximately 2 inches below injection site.
Psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.  No Medical History information was reported.  On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis). At the time of the report, PSORIASIS (Psoriasis) had not resolved.     No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.