chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is one case out of a cumulative total of 21 cases received during the surveillance period from 01 January 2010 to 06 June 2011. Initial report received on 06 June 2011 from the investigator participating in post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the system. The subject's vaccine history included one dose of DAPTACEL; lot number C3192BA received on 08 June 2010 and three prior doses of PENTACEL; lot number C3162BA received on 14 July 2009, lot number C3166AA received on 13 April 2009, and lot number C2881AA received on 23 February 2009 (lot numbers were consistent for DTAP-IPV component of PENTACEL; route and sites of administration not reported). The subject developed cold-like symptoms approximately 10 months after the last dose. On 08 April 2011, the subject developed a paroxysmal cough without a whoop. He also experienced posttussive vomiting. Laboratory testing included positive PCR on 14 April 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 14 April 2011 for five days. The subject was not hospitalized. At the time of final contact 20 April 2011, the subject's cough had resolved. The duration of the cough was reported at the time of as 18 days. Investigator causality assessment is not required per protocol. Documents held by sender: None.
The syringe and needle detached at the connection point. Resulted in unknown amount of vaccine administered and splashed out.
I receieved the Moderna booster on 11/27/ 2021.  THe next day I had severe headaches on the very top of my head. Later, a blood clot developed in my right leg, from the upper thigh down to below the calf.  I am not an anti vaccine type.  I got the 2 Moderna shots and then did the booster.  By the grace of God I took a lot of aspirin.  I assumed my pain and swelling in my leg were due to a bad knee and the weather.  There is a very strong correlation here that i feel I need to mention.  Now I am on blood thinners.
Patient developed cellulitis at the site of the injection in the right arm 1 day after vaccination.  Required a doctors visit, IM antibiotic injection at the clinic and oral antibiotics.
Patient is feeling dizzy and having trouble breathing. I asked the patient how he was feeling. Patient states that he is feeling like his heart is racing and still feeling dizzy . Took the patients vitals at 12:05 pm heart rate 126, o2 99, blood pressure 191/125, at 12:10 pm heart rate 123, o2 100, blood pressure 170/113, at 12:13 am heart rate 107, o2 99, blood pressure 161/111, at 12:18 pm heart rate 96, o2 99, blood pressure 152/99, and again at 12:23 pm blood pressure was 156/99. I asked how patient was feeling and he stated that the dizziness was a little better but still felt weak.. I asked the patient how he was feeling. The patient stated that he still feels dizzy and weak.
Info has been received from a woman in a doctor's office concerning a 74 year old female who on 05/14/2002 (also reported as 05/23/2002) was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641115/1159L). "The next day", on 05/15/2002, or 05/24/2002, the pt developed local redness, local soreness and local swelling. Subsequently the pt recovered. Unspecified medical attention was sought. The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evalation and Research and was released. It was also noted that similar experiences occurred with other patients from the same source (WAES #'s 0206USA00271 and 0206USA00884). Additional info has been requested.
Swelling @ inject site, warm & red w/in 1/2hr p/inject; 22hrs later developed diarrhea;
This spontaneous report as received from a healthcare worker/certified medical assistant refers to five patients of unspecified demographics. The patients received improperly stored VARIVAX with possible lot/expiration dates as follows: L019124/27-MAY-2017, reported as L027288/21-JUL-2017, L013064/14-APR-2017, and/or L025209/07-JUL-2017 on multiple unspecified dates ranging from 20-NOV-2015 through 30-NOV-2015. No adverse effects were reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Fever of 101; Dizzy/Lightheaded; Chills; Chest pain; I just had arm pain; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient experienced fever of 101 (unit unspecified), felt dizzy, lightheaded, chills, chest pain and had arm pain; all on an unspecified date. The patient reportedly took paracetamol (TYLENOL) as treatment for the events reported. Outcome of events was unknown.  Information on the Lot/Batch number has been requested.
This spontaneous report was received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 31-JAN-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M018957, expiration date: 22-NOV-2017, as prophylaxis (Strength and dose were not reported), which experienced a temperature excursion between 46 and 77 Fahrenheit degrees for 1 hour. No previous temperature excursions were reported. Digital data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of two reports received from the same patient. Additional information has been requested. Sender's Comments: US-009507513-1702USA004906.
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a mother regarding her 7 year old son who "got the flu."  The pt received the first dose on 12/11/03. It was reported that the child had no medical history.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 0.5mL (IN).  Pt was not taking concomitant therapy.  The mother reported that on 12/14/03, three days post-immunization, her son "got the flu," experiencing a fever of 103 deg. F, nasal congestion, and body aches.  The symptoms persisted until 12/16/03, resolving without treatment.  No additional information was available at the time of this report.
Patient received Pneumonia vaccine 10/31/12. Came back to see MD today 11-01-12 complaining of (R) shoulder pain, swelling - nausea & dizziness. Tx: warm compress, steroid taper, OTC antihistamine. KEFLEX 500mg 3x day for 10 days.
Pt received covid vaccine at 3pm, then flu shot 5 minutes later, then 5 minutes after that had hives on face, chest, and neck. hives began improving 15 minutes later on face, but still has hives on chest and neck.
Patient got COVID-19 but unspecified if he got Moderna COVID-19 Vaccine before; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient got COVID-19 but unspecified if he got Moderna COVID-19 Vaccine before) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient got COVID-19 but unspecified if he got Moderna COVID-19 Vaccine before). The patient was treated with IVERMECTIN for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient got COVID-19 but unspecified if he got Moderna COVID-19 Vaccine before) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.         No concomitant medications were reported. It was reported that patient got COVID-19 but he took Ivermectin and 2 days later he tested negative. It was unknown whether he had received Moderna COVID-19 Vaccine.   Reporter did not allow further contact
I had 2 friends who got shingles after the first shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The reporter stated that the patient got shingles after the 1st shot of Shingrix. The information regarding consent to follow up was not reported. No other information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR041568:Same reporter, different patient (Friend 2/2)
Information has been received from a nurse practitioner concerning unspecified number of patients. Between 06-APR-2015 and 30-APR-2015, the unspecified patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, strength, lot# and route were not reported). No adverse effects were reported. Additional information has been requested.
Large volume of emesis uncharacteristic of any previous reflux events. Total volume approximately 3-4 ounces.
No additional AE reported; improperly stored vaccine was administered; This spontaneous report was received from an office manager referring to a 9-month-old patient of unknown gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 06-MAY-2022, the patient received improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot # T042013, expiration date: 22-JUL-2023, strength, dose and route were unknown) for prophylaxis (product storage error). The vaccine was exposed to 11.43 degrees Celsius for 4 hours and 45 minutes. There was no previous temperature excursion. No additional adverse event was reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2205USA003131: US-009507513-2205USA002848: US-009507513-2205USA002913: US-009507513-2205USA002951: US-009507513-2205USA002965: US-009507513-2205USA002988: US-009507513-2205USA003043: US-009507513-2205USA003118: US-009507513-2205USA003266:
Redness at injection site appeared immediately. Patient came home and began experiencing dizziness, low grade fever, chills, shivering, fatigue, and joint pain. Next day, 2/14/19, a painful area of about  5x3 inch appeared to be swollen, red and raised around the injection site.
Eight days after the Covid injection, I had intense itching at the injection site.  Upon investigating, I had a huge welt 2 1/2 inches in diameter that itched obsessively.  The center of the welt was a white spot that was probably the injection site.  Several peripheral red spots were evident, probably from the intense itching.  I had noticed no issues in the days leading up to the 8th day.
Warm to the touch; Redness at the site of injection; Swelling at site of injection; Pain at site of injection; A spontaneous report was received from a other health care professional concerning a 36-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain at site of injection, swelling at site of injection, feeling hot and vaccination site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(lot number: 025J20-2A) intramuscularly for the prophylaxis of COVID-19 infection.  On 28 Dec 2020, she started experiencing pain at site of injection, redness, swelling at site of injection for a while after a day of vaccine, pain then subsided for most part was gone, redness in oval below the site of injection a day after vaccine it now feels warm to the touch.  The action was taken with mRNA-1273 in response to the events was unknown.  The outcome of al events were recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Caller reports that it felt like his throat was closing, narrowing a bit, and felt like something was stuck in his throat; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 18May2021 (at the age of 49-years-old) as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 18May2021, the patient stated he got his shot about 30 minutes ago and it felt like there was a lump in his throat, and it felt abnormal, almost like his throat was closing a little bit. He stayed for observation for 15 minutes, and when he was driving home, it felt like his throat was closing, narrowing a bit, and felt like something was stuck in his throat. The outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected
24 hours after the shot, I started with chills not just normal chills freezing chills my fingers snd my toes were burning with pain but to touch they were like ice cubes.  My arm where I had the shot was extremely painful I could not move it without screaming pain. I took an ibuprofen and  about an hour later I was fine . But still not feeling myself.. during the night I started feeling sick my head hurt and my chest felt heavy and I started coughing.. I feel as if I have the flu  and this moment .. my left side waist down down hurts when I walk shooting pains. It?s 9:30 am
2 min p/receiving 3rd immun passed out, had sz like movements first aid given; sen to ER via ambulance;
Information has been received from a physician concerning a young male patient who on an unknown date was vaccinated with a dose of ROTATEQ (dose, route and lot # not reported). The patient was admitted to the hospital for intussusception 2 days after ROTATEQ was given. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
24 hrs post, started itching, 48 hrs red rash, warm to touch, 6-7 inches in diameter.
15 year old patient came in to receive first dose of Covid-19 vaccine. His mother asked for him to receive Moderna and vaccine administrator did not realize that Moderna was not approved for patients under the age of 18. Dose was administered.
Patient experienced swelling, redness and itching of injection site and upper arm on which vaccine was administered which lasted for over a week.
Information has been received from a registered nurse concerning an 18 month old female who on 31-JAN-2007 was vaccinated with a 0.5 ml dose of hepatitis A virus vaccine inactivated. On 31-JAN-2007, after vaccination, the patient experienced a rash on her face, lips and neck. Shortly after developing the rash the patient had swelling of the lips and face. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
No adverse event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 48-year-old 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.    Concurrent medical conditions included Gout.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-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) 1 dosage form. On 22-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  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.   This case was linked to MOD-2021-623510 (Patient Link).
Gardasil was given in office. Pt. reported only some irritation at site following the administration of vaccine. The following day she developed local erythema and sm. blister. She was seen again in the office on 1/25/07. Superficial blister/inflammation of approx. 0.5 x 1.5cm was noted. No cellulitis noted. Area was lt. pink in color. Advised pt. to keep area clean and dry, apply antibiotic oint. if desired. Only local treatment needed. No further treatment anticipated.
61-year-old female is coming in today to ED for difficulty breathing.  States been going on for the past 2 weeks intermittently.  Producing sputum.  No fevers or chills no chest pain.  States that she fell yesterday trying to get in her house slipped and hit her leg.  No abdominal pain no nausea or vomiting.  patient is in mild respiratory distress.  Patient has rhonchi bilaterally and wet cough heard.
Patient developed a hard, raised area slightly bigger than a quarter at the site of injection right after vaccine was administered.
devel gen hives 4hr p/vax;had been on amoxicillin last dose Am;
Dizziness, Myalgia, Diarrhea, NauseaVomiting, flushed Narrative:
- Mild muscle soreness in trapezoids 3-4 hours after injection - Fever onset 9 hours after injection - Tingle/Numbness in toes and fingers for an hour about 9 hours after injection -Shivering  - Peak fever 102.0 F for 3 hours, 11 hours after injection  - Continued increased temperature (over 99.5) for 24 hours after injection - Chills - Significant body aches and lethargy  for 36 hours after injection - Mild body aches and low energy for 48 hours after injection
approx 18 - 19 hours after shot, having had arm soreness, tiredness and low grade fever, woke up in morning with sweats and headache. Got up to get drink in kitchen to wash down Advil with, got dizzy, fainted and fell to floor. Time down unknown but very short duration. Stood up with dripping sweat and felt like was going to vomit. Had dry heaves but did not vomit. Rest of day tired and sore, woke up next morning perfectly fine and feeling good.
Mom reported "with one hour of vaccine given on 12/19/2017 the patient had a fever of 105 F. With TYLENOL the fever went down to 101.9 and stayed there for two days." The mom reported lethargy but no seizures or inconsolable crying. The PCP office has record of a telephone call on 12/20/18 from the mom stating the child is "running fever of 102." MD office advised mom give MOTRIN and to call back if fever did not improve. PCP office reports having a record of a phone call back to the parent on 12/20/2017 and indicates the parent stated "the child's temperature was down to 100 and seems better."
Information has been received from a physician, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 15 years old female patient with no drug allergies. The other medical history included eczema. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with dose 2 0.5 ml VARIVAX (Merck) (lot# was reported as HQ4272, expiration date not reported) subcutaneously on 26-OCT-2012. There was no concomitant medications. The patient was pregnant when received dose vaccine. A urine pregnancy test was done during the same office visit and it was negative. However, a serum pregnancy test was done at a later time and the result came back on 12-NOV-2012 and it was positive. The first dose of The VARIVAX (Merck)(lot# and expiration date were unknown) was provided by a different provider on an unspecified date. LMP was on approximately November 2012 and EDD will be approximately in August 2013. The patient was exposed to VARIVAX (Merck) during trimester 1. The patient sought medical attention through office visit and no treatment was given. Additional information has been requested. Lot number HQ4272 is an invalid lot number for VARIVAX.
Information has been received from an unspecified reporter referring to a 6 week old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 23-SEP-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
GOLF BALL SIZE PUFFED UP AREA WHERE THE INJECTION WAS; CHILLS; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced golf ball size puffed up area where the injection was, chills, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The batch number was not reported and has been requested. The outcome of the golf ball size puffed up area where the injection was, chills and tiredness was not reported. This report was non-serious.
Case number PHEH2016US029321, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 42 years old male patient. Past medical history and concomitant medications were not reported. The nurse stated that first temperature excursion of FLUCELVAX Quadrivalent at 52F for 1 hour occurred on 18 Oct 2016. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscularly on 26 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34F and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2F three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
Sore at the injection site, dizzy, chills, vomiting, feverish, tired, back pain