chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This 43 yo AD service member reported receipt of typhoid, AVA#1 and HepB #1 on 3/3/11 with no systemic adverse events. She did c/o nodule formation to her left deltoid lasting about 1 month. It resolved about 1-2 days before receipt of AVA#2 and HepB #2 on 4/4/2011, again to left deltoid. She denied any adverse events other than site tenderness when she received her primary SPV on 4/8/2011 to left deltoid. Approximately day 4-5, she experienced a dull frontal and occipital headache 5/10 self treating with OTC MOTRIN w/relief. She attributed this headache to onset of menses (headache similar to past menstrual headaches). Approximately day 6-7, her SPV site began to redden, swell and itch with skin tenderness under bandage. Day 8 (4/16/11) she c/o of left axillary node swelling and tenderness. On day 11 (4/19/11), while returning from where she was visiting family (4/16-19/11), she c/o scattered red macular spots on left then right forearms, right shoulder, neck and hairline and a mild headache and neck ache which eased by rubbing her neck and use of MOTRIN. She self treated her pruritic red spots with her son's Trimincinalone thinking she has poison ivy (not put on SPV site). She had mowed the lawn 24 hours before with possible exposure to area known to have had poison ivy; however she did not remember seeing any. Day 12 (4/20/2011) she presented to medical clinic complaining of a mild fever (99.2 F) with skin lesions and was transferred to another clinic for further evaluation. She advised she had kept her SPV site covered utilizing large bandaids with resulting skin irritation around SPV site most likely from the bandage adhesive. On day 13 (4/22/2011) her lesions had expanded to her arms, forearms, hands (including hypothenar regions), and 2 papules to left anterior thigh. She c/o tender pinpoint red macules to anterior hairline and behind her left ear. Macules to arms and hands were tender, especially to hypothenar regions. As of 4/25/2011 SM reported skin lesions were almost resolved with dark patch skin discoloration at sites. She continued to experience tenderness along the hypothenar region of the right hand. She denied any headaches, myalgia, fevers, or new symptomatology. She is using Clodetasol cream to sites. 5/5/2011 full resolution of rash with some scaring.
The evening after my vaccine, I had fever, chills and backpain for about 12 hours. the next evening my Scutum itched and then swelled up triple it's regular size for about 12 hours.
Severe migraine with throbbing headache, extreme scalp sensitivity, still persisting after 5 days
After 24 hrs, patient developed a fever, local swelling on injection site > than patient's hand, tenderness, flu-like symptoms. Swelling persisted for 3 days.
QUARTER SIZE WELT PAINFUL AND ITCHY; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F.  On an unspecified date, the subject experienced quarter size welt painful and itchy, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the quarter size welt painful and itchy, fever and headache was not reported. This report was non-serious.
Shots at 2:30pm 12/30/08 Slight headache in afternoon, Oral Typhoid stated that evening, 2 hours later became sick. Symptoms nausea and low grade fever, woke during night feeling sick, 12/31/08 5am feeling rotten. Nausea and vomiting almost constant all morning. Fever 104. Sleeping in afternoon, 800 mg Ibuprofen, antinausea pill, Slept most of evening and night.  Left arm where Tdap was given sollen and red, felt fverish and achey.  1/01/09 Same symptoms as day before stated all over again. Not able to sleep. That evening was seen in ER. IV fluids given.   1-2 and 1-3-09 continued sick, couldn't eat. Ontinued with 102 fever.1/04/09 Feeling itchy  upper half of body.  It took almost 8 days before feeling well again.  Fingers in left arm tingly next day of vaccine.
Woke up at 3am with a very severe headache 10 hours after the shot. Lasted all day and I was nauseated and vomiting  I called the doctor on call and was told to take Tylenol which I did and started to feel better. The headache lasted for two more days but not nearly as intense
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; ACETYLSALICYLIC ACID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures (COVID 19 Treatment, Paxlovid treatment start date: 19May2022 and treatment stop date: 24May2022) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Patient was admitted to the hospital twice within 6 weeks of receiving covid vaccination. DOS: 2/11/21 and 2/16/21.
Not adverse reaction, just a strange thing. I got my period a week early the day after receiving vaccine. This is unheard of. My period is like clockwork- a 28-day cycle, never early. Also very heavy.  My coworker who has been in menopause for six months had spotting after her second shot. The vaccine does something to women's hormones.
Spinal column and shoulders started aching. During he night all joints and nerves aches in my entire body. Woke up with a fever, took ibuprofen. It did nothing fir the pain. Pain lasted all day Thursday and Friday. Fever reached 102.4 on Thursday after taking 8 - 200 milligrams of ibuprofen and two 500 milligrams of Tylenol. Fever dropped To a low grade fever Friday afternoon. Fever still persist, but low at 100.1.
Increased Urination - current Inability to withhold urine - current Whole body muscle aches - 2 days Sick feeling  - current Fever - 1 day, no longer affected Chills - 1 day, no longer affected
Patient developed chest pain  1 day following 2nd Pfizer COVID 19 vaccination. Worsened over 3 days; family spoke to PCP who recommended ED evaluation.  Found to have elevated troponin and BNP in ED and subsequently admitted for further evaluation and monitoring.
5 minutes after receiving vaccines hands & feet red. Various size bumps over body & itching swollen (R) ear- no shortness of breath or wheezing.
Information has been received from a Licensed Practitioner Nurse concerning a male patient (age not reported) who on 11-MAR-2014, was vaccinated inadvertently with a dose of PROQUAD (Merck) (Batch J014238, exp. 07-MAY-2015) (dose, route and site of administration were not reported) instead of a dose of M-M-R. Before been administered the PROQUAD (Merck) was exposed to an unsupported temperature excursion. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Large about 5 x 5 cm erythematous, indurated, raised lesions at immunization sites and thighs.
rattling in lungs, hoarseness, could hardly talk, coughed up pinkish colored stuff, severe difficulty breathing
Running nose; Then stuffy nose; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Pfizer Ewo170) via an unspecified route of administration in the left arm on 20May2021 at 16:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have any known allergies. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21May2021, the patient experienced running nose and then stuffy nose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events running nose and stuffy nose was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
AT 10:52AM ON 08/31/2021, PATIENT RECEIVED FIRST PFIZER COVID VACCINE. AT  APPROXIMATELY 6:30 PM, PATIENT CALLED PHARMACY COMPLAINING THAT HE WAS HAVING A REACTION TO THE COVID VACCINE AND WAS EXPERIENCING NAUSEA AND A SENSATION THAT HIS LUNGS WERE "ON FIRE." HE STATED THAT THESE SYMPTOMS BEGAN AROUND 5:20PM AND WAS ONGOING.  UPON FURTHER QUESTIONING, PATIENT STATED THAT THE NAUSEA HAD BEGAN TO WAX AND WANE, BUT THAT NUMBNESS BEGAN TO DEVELOP IN HIS ARMS AND HANDS.  PATIENT STATED THAT HE HAD BEGAN ASHWAGANDHA RECENTLY WITHOUT INFORMING PCP OR PHARMACY.  UPON FURTHER QUESTIONING, PATIENT REVEALED THAT HE HAD 2 PRIOR MYOCARDIAL INFARCTIONS.  I STRONGLY RECOMMENDED THAT THE PATIENT GO TO THE ER AS I BELIEVED THESE WERE SYMPTOMS OF AN MI. PATIENT AGREED.
her doctor reported to her that another female patient also had neuropathy in the feet; "hemochromatosis" 2 weeks after she received her 2nd moderna dose; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (her doctor reported to her that another female patient also had neuropathy in the feet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (her doctor reported to her that another female patient also had neuropathy in the feet) (seriousness criterion medically significant) and HAEMOCHROMATOSIS ("hemochromatosis" 2 weeks after she received her 2nd moderna dose). At the time of the report, NEUROPATHY PERIPHERAL (her doctor reported to her that another female patient also had neuropathy in the feet) and HAEMOCHROMATOSIS ("hemochromatosis" 2 weeks after she received her 2nd moderna dose) outcome was unknown.            Company Comment: This is a spontaneous case concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Neuropathy peripheral, and the unexpected and non-serious event of Hemochromatosis. Neuropathy peripheral occurred on an unknown date related to the second dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests, performed, clinical course or treatments received. Hemochromatosis could be a risk factor for Neuropathy peripheral. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  No concomitant medication details provided. No treatment medication details provided.  The reporter stated that her doctor reported to her that another female patient also had neuropathy in the feet and hemochromatosis 2 weeks after she received her 2nd moderna dose as she stated that same thing happened to the other patient.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Upon internal review on 13-Jun-2023, significant correction was performed to upgrade the event neuropathy peripheral to serious medically significant. On 13-Dec-2021: Follow-up received on 13-Dec-2021 included no new information.
About 15 minutes after vaccine administered pt complained about a funny taste in her mouth - her face was going numb and her left arm was going numb on the way to the ER - her face broke out in hives.
Body aches; Arm soreness; Severe chills; Fever of 100.6F; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PAIN IN EXTREMITY (Arm soreness), CHILLS (Severe chills), PYREXIA (Fever of 100.6F) and FATIGUE (Fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concomitant products included METRONIDAZOLE and ESTRADIOL (IMVEXXY) for an unknown indication.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (Body aches), PAIN IN EXTREMITY (Arm soreness), CHILLS (Severe chills), PYREXIA (Fever of 100.6F) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Body aches), PAIN IN EXTREMITY (Arm soreness), CHILLS (Severe chills), PYREXIA (Fever of 100.6F) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Pyrexia: 100.6 (Inconclusive) fever of 100.6F.         Concomitant also include inflammatory bowel syndrome medications.  Tylenol is used as treatment medication. Action taken with mRNA-1273 in response to the events was not Applicable.
Issue overlapped between both vaccines.   In all fairness, I've had this issue before, so I see my eye doctor regularly. However, this time it was more severe. Every morning the white parts of everything was pink, which has happened before. I went to the doctor because I started having visual disturbances and pain in my left eye. It got to the point to where I couldn't drive. I went to the wrong facility, so they had to reschedule me for the following Monday.  I saw Dr. set me up the see another Dr. on 3/31 because she determined that something was going on with my optic nerve in both eyes. I was given the worst case scenario, which is a tumor, and sent me to have an MRI on 4/28. I went back to see Dr.  on 5/19. He did more testing and said that he sees pressure in both eyes, but the left is worse. The MRI showed a possible tumor and the only way to confirm everything is through a spinal tap, which I'm not agreeing to due to previous issues with my spine. He told me to rest, use moisturizing drops (which now burn) and return to see him in 3-4 months, unless I have another episode where everything goes reddish again.
Severe swelling of upper arm persisting 7 days total, immobilizing arm and neck pain with severe headache. Body shakes due to chills, full body aches.
Headache Chills Fever All lasted for roughly 24 hours Symptoms started roughly 14 hours after receiving the vaccine
Agitation Narrative:  At 14:28 reported" I need help, I don't feel good." Reported feeling a burning sensation all over body, remarked it felt like she was having a CT with contrast. No flushing, No SOB or chest tightness. B/P 122/81; P 122; R 23; O2@96% on room air. Recheck P = 84. Fidgety & tapping foot. Took dose of own anxiety med. Independently ambulated to front door for discharge@ 3:15pm.  Other Relevant History:
Information has been received from a pharmacist referring to a 60 year old patient of unknown gender. No relevant medical history or concurrent conditions were reported. On 19-MAR-2015 the patient was vaccinated with ZOSTAVAX 19400 plaque forming unit (PFU) (dose and route not reported; lot# K015311, expiration date 17-DEC-2015). On an unknown date in 2015 the patient experienced an unspecified adverse event due to which the patient was prescribed BACTRIM (unspecified manufacturer). BACTRIM was not started by the patient yet. The outcome of the event was unknown. Additional information has been requested.
Injection site began to swell up. Other than that, patient feels fine. No other symptoms.
Information has been received from a physician, who was not the treating physician (overheard the treating physician discussing this in a hospital hallway), concerning a female patient who on an unspecified date was vaccinated with a 0.5 mL dose of GARDASIL. It was reported that "in the last two weeks", approximately on 23-DEC-2009, the patient experienced a syncope event after receiving GARDASIL. It was reported that "the office did not keep the patient in the office after receiving GARDASIL to make sure she did not have a syncope event, and the patient left the office and fell backwards on tile flooring, hitting the back of her head, and developed a subdural hematoma from result of the fall". The patient was sent to the Emergency Room for treatment, but it was not known at this time whether the patient required further hospitalization. At the time of the report the outcome of the patient was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. No further information is available.
Rash (about 75 minutes after immunization) - 50 mg total diphenhydramine liquid 12.5 mg / 5 ml; difficulty breathing (about 90 minutes after immunization) - called 911, who responded and took over treatment (no further info).
Pt recv vax on 2/8/99; on 2/9/99 pt exp swelling, joint pain, fever, pain to left scapula, arm warm
Stated was dizzy, pale, hot and had some difficulty breathing. Given 40ml of Benadryl and put an ice pack on back of neck. Color returned after 10 minutes and breathing improved. Stated felt fine and went back to work.
1:30 pm Patient states was feeling light headed, dizzy but has passed, patient stated has anxiety and panic attacks. Skin cool and dry to touch, color pink, respirations 20.  nurse instructed to continue to sit in waiting room take deep breathes will check on her in a few minutes. 1:40 pm nurse check on patient was doing ok but states still felt funny. remains alert, oriented and without distress  1:49 Pt states feels heaviness in chest BP156/102 HR 84 Resp 20, called 911.  1:54pm BP 144/100 HR 89 Resp 16. Patient remains alert, orient and without diaphoresis. States it could be anxiety. EMS arrived 2:00 patient able to walk to ambulance for assessment and  EKG. EMS state EKG normal recommend waiting 5 more minutes in lobby and if unable to drive call for assistance and follow up with private medical doctor.
Tenderness and swelling at the site high fever for 4-5 days Fever up to 103 deg
Received PCV 13 and Influenza same day. Started with high fever and febrile seizure.
It exacerbated the the light headedness and dizziness. I have been experiencing since the start of covid pandemic. Not as much as the 2nd vaccine did, but it brought it up again. For the dizziness when it gets really bad I go to the hospital at the balance center to help me with that. And I also go to eye doctor here, and one of the things they do with people in my situation is treat them similar to patients who have concussions since the symptoms are the same. Neuro optometric rehabilitation.
Adverse event happened immediately after injection. Heat wave, rapid heart rate, increase respirations, feeling of water dripping inside my arm, High Blood Pressure. Since then I have had feelings of "vibrations" running up and down my spine, arms, head, neck, chest, legs. I have been to the Chiropractor, Urgent Care Clinic, PCP, ER. Waiting to see a Neurologist... All of these symptoms happened after the 1st dose of the covid vaccine, and have worsened each day since.  January 18 2021 to Current date. I have a detailed list of times, dates, and actions.
Pt broke out in hives shortly after the vaccine was administered.  Pt mom gave her BENADRYL and it went away.
Dizziness, high blood pressure SBP 180s, DBP 90s.
Swelling of face, decreased vision, fatigue, diaphoresis, diarrhea, vomiting, bilateral ear pain and tenderness, scalp tenderness. Optometrist diagnosed increased retinal leakage.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 13-JUL-2015, the patient was vaccinated with a dose of improperly stored MMR II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Moderna COVID-19 EUA. Received booster dose of Moderna on 11/10/21 and on 11/24/21 noticed a palm sized area of redness to the front of her neck that is itchy. This has been treated with over the counter topical benadryl and is a very pale pink area as of today, but it is still itchy and becomes bright red with exercise or stress. Has not seen a physician for any further treatment at this time.
Hives occurred approximately 30 hours after vaccination. It persisted for about 2 weeks afterwards and was severe enough that I had trouble sleeping for over a week. I only slept every other night due to the itching.
Per mother pt. awoke this morning not feeling well. Since then he has begun vomiting and feeling itchy all over. He has redness and swelling under both arms and in his throat. He states his nasal passages and mouth feel swollen. He took BENADRYL and relief. Referred to ER STAT. Pt had previous allergic RXN to something he drank in high school. No temperature was taken today.
This spontaneous report as received from a Nurse Practitioner refers to a patient of unknown age and gender. The patient's concurrent condition and medical history were not provided. On 08-JUL-2015 the patient received the one dose of GARDASIL (strength, frequency and lot number were not reported). Concomitant medications were not provided. On 06-NOV-2016 and 18-JAN-2016 the patient received GARDASIL 9 (dose 1 and dose 2 respectively, strength, frequency and lot number were not reported) to complete their hpv series (inappropriate schedule of drug administration) (wrong drug administered). No adverse effects reported. Causality assessment was not provided. Additional information has been requested.
[Moderna Vaccine] use for COVID-19 under Emergency Use Authorization (EAU): Patient having shoulder pain that increased with 3rd dose of vaccine. The patient states shoulder pain "in the section that connects between arm and shoulder". On a scale of 1-10, with 10 being severe "8".
Covid arm reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm reaction) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (Covid arm reaction). At the time of the report, VACCINATION SITE REACTION (Covid arm reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug details were reported. No treatment details were reported.  The patient had COVID arm reaction on the arm that came 7 days later but went away after a couple of days.   This case was linked to MOD-2021-418247 (Patient Link).