chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site is continuing to red and swell; continued to get redder larger and itching; Injection site is continuing to red and swell; continued to get redder larger and itching; Injection site is continuing to red and swell; continued to get redder larger and itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 24Jun2021 (Lot number: EW0183) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Tachycardia" (unspecified if ongoing); "Hypersensitivity" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA; METOPROLOL; MONTELUKAST taken for hypersensitivity. Vaccination history included: Bnt162b2 (Dose: 01), administration date: 2021, for COVID-19 Immunization. The following information was reported: INJECTION SITE ERYTHEMA (non-serious), INJECTION SITE SWELLING (non-serious), INJECTION SITE PRURITUS (non-serious) all with onset 25Jun2021, outcome "not recovered" and all described as "Injection site is continuing to red and swell; continued to get redder larger and itching". Therapeutic measures were not taken as a result of injection site erythema, injection site swelling, injection site pruritus.  Additional Information:It was reported that, Reaction/event as reported by primary source: Injection site is continuing to red and swell; continued to get redder larger and itching. Date of start of reaction/event: 25Jun2021. Outcome of reaction/event at the time of last observation: NOT RECOVERED/NOT RESOLVED. When probed for the consumer stated, "I am concerned because I had the Covid Vaccine (second dose) last Thursday (24Jun2021) and the injection site is continuing to red and swell." When paraphrased the concern, consumer stated, "Yes, I want to know is that normal." Consumer was informed about the Role of Pfizer Drug Safety. When probed for vaccine (second dose) NDC#, consumer stated, "No." When probed for vaccine (second dose) expiration date, consumer stated, "They don't have that on there either, anything expect from the LOT. When probed for any laboratory test and its date, consumer stated, "My internal medication Doctor did my lab work probably in April." When probed for ay treatment for event, consumer stated, "No, It's worsening that's why I am calling you."  Follow-Up (22Jul2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Extremely sore arm (that received the injection) to the point of not being able to move the arm. First symptom. A few hours after injection: Foggy brain, light headed Headache Fatigue 24 hours later: Fever Entire body aches to the point I couldn't get out of bed Chills Extreme fatigue
Transient bulging anterior fontanelle for 3 days, fever for 3 days.  Underwent full sepsis workup and received IV antibiotics for 48 hours, pending negative cultures.  Admitted to Hospital 5/14/08-records received for DOS 5/9-5/10/08-DC DX: Bulging fontanelle, R/O meningitis. Presented to ED wtih noticeable fontanel bulging out. PE:anterior fontanel bulging. Temp 100.4 tympanic.
LIGHT HEADEDNESS; This spontaneous report received from a patient concerned a male 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, 1 total, administered on 13-MAR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 13-MAR-2021, the subject experienced light headedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headedness on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210355509.
Arm to be swollen, red and hard as a rock; have a dull headache; Just like the first shot, the shot caused them to get their arm to be swollen, red and hard as a rock,; Just like the first shot, the shot caused them to get their arm to be swollen, red and hard as a rock,; It is swollen and very tender; felt a lot of tiredness; felt the worst ,felt miserable; Fever; Chills; Very Sick; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (It is swollen and very tender), ILLNESS (Very Sick), FEELING ABNORMAL (felt the worst ,felt miserable), VACCINATION SITE INDURATION (Arm to be swollen, red and hard as a rock) and HEADACHE (have a dull headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical information provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]), HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE [HYDROXYCHLOROQUINE SULFATE]), DICLOFENAC, LOSARTAN, METOPROLOL, LEVOTHYROXINE, TIZANIDINE, VITAMIN D [VITAMIN D NOS] and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 05-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Oct-2021, the patient experienced FEELING ABNORMAL (felt the worst ,felt miserable), PYREXIA (Fever) and CHILLS (Chills). On 08-Oct-2021, the patient experienced FATIGUE (felt a lot of tiredness). In October 2021, the patient experienced ILLNESS (Very Sick). On an unknown date, the patient experienced TENDERNESS (It is swollen and very tender), VACCINATION SITE INDURATION (Arm to be swollen, red and hard as a rock), HEADACHE (have a dull headache), VACCINATION SITE SWELLING (Just like the first shot, the shot caused them to get their arm to be swollen, red and hard as a rock,) and VACCINATION SITE ERYTHEMA (Just like the first shot, the shot caused them to get their arm to be swollen, red and hard as a rock,). At the time of the report, TENDERNESS (It is swollen and very tender), VACCINATION SITE INDURATION (Arm to be swollen, red and hard as a rock), HEADACHE (have a dull headache), VACCINATION SITE SWELLING (Just like the first shot, the shot caused them to get their arm to be swollen, red and hard as a rock,) and VACCINATION SITE ERYTHEMA (Just like the first shot, the shot caused them to get their arm to be swollen, red and hard as a rock,) outcome was unknown and ILLNESS (Very Sick), FEELING ABNORMAL (felt the worst ,felt miserable), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (felt a lot of tiredness) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medication reported.   This case was linked to MOD-2021-376972 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow-up received on 10-NOV-2021 contains reporter details, patient demographical details, anatomical location, concomitants and new adverse events added.
Pain and numbness in right arm.  Loss of strength. Been taking otc Tylenol, sometimes otc ibuprofen. Recently prescribed 800mg ibuprofen but have not taken any at present time
My throat started closing up I was rushed in an ambulance. I started to have problems breathing after 11-13 minutes . I was given an epi pen, Benadryl, breathing treatment and steroid shot. Since the vaccine I?ve been having breathing problems and a cough every now and then.
pt recvd vax;sz & t 103 x 36 hrs p/ vax;to er;given valium; stabilized & placed in pedi-ICU;discharged p/ 4 days on phenobarbitol;has had 2 brain surgeries to control the sz;
VS WNL.  Complains of tight throat.  Symptoms resolved with observation and  provided OJ and crackers before departure.
Pain; Fertility test showed no eggs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and INFERTILITY FEMALE (Fertility test showed no eggs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain) and INFERTILITY FEMALE (Fertility test showed no eggs). At the time of the report, PAIN (Pain) and INFERTILITY FEMALE (Fertility test showed no eggs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant and treatment medications were provided
This spontaneous report as received from a certified medical assistant, refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported for the patients. On an unspecified date in 2015, starting from and after 03-AUG-2015, the unspecified patients were vaccinated with improperly stored doses of VARIVAX lot # K006133, expiration date 29-APR-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a registered nurse concerning a pt who on 07/24/2000 was vaccinated with one dose of varicella vaccine. The pt developed chicken pox the week of 04/23/2001. It was unknown if medical attention was sought. Also reported was an other pt who was vaccinated and experienced similar events. Additional info has been requested.
Given 4 vaccines, assisted mother in holding brother so brother could receive vaccines. Approx 7-10 min after pt received vaccines and after brother received vaccine, fainted, child had sweats on warm in room, out approx 30-40 seconds. VSS did hit head on wall, no lump felt, alert, oriented x 3, appro answers to question. To ER per director request, VIA private car. FU PC to mother at 1600 child doing well. ER DR thought it was a nerve RX of some kind asked if vagal mother said yes.
She slept for 16 hours straight. Did not wake up to feed. Was extremely lethargic when trying to arouse. Mother states daughter returned to normal about 4 weeks after vaccination.
Information has been received from a licensed practical nurse concerning an adult female patient who was vaccinated on an unspecified date with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. It was reported that the patient had been vaccinated with measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine live twice over the last ten years. Recent titers do not show that the patient had developed immunity against mumps. Unspecified medical attention was sought. It was reported that no treatment was required. Additional information has been requested.
Pregnancy; A spontaneous report was received from a consumer who was also a 36-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) while patient was pregnant/exposure during pregnancy.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient received a positive pregnancy test on an unspecified date. Last menstrual date and conception date was not provided. The patient's estimated due date is on 18 Jun 2021.  On 13 Jan 2021 at 03:00 pm the patient was exposed to the mRNA-1273.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided. The event, vaccine exposure during pregnancy, was recovered on 13 Jan 2021.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Entirely debilitated for the day (unable to do anything); Extreme exhaustion; Severe headache; Muscle pain; Sweating; Joint pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN2613) via an unspecified route of administration in the left arm on 26Mar2021 at 10:15 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, hypothyroidism, kidney stones and had severe COVID in Oct2020, requiring hospitalization. Concomitant medications included levothyroxine sodium (SYNTHROID), sertraline (MANUFACTURER UNKNOWN), potassium citrate (MANUFACTURER UNKNOWN) and trazodone hydrochloride (DEPRAX) for unspecified indication from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 02:00 for 3 days after the vaccine, the patient was in bed with all the less severe side effects, however unable to do anything. It went away on day 4, however every third day however every third day since then the side effects return to the point where the patient entirely debilitated for the day. Extreme exhaustion, severe headache, muscle pain, sweating, joint pain. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the events entirely debilitated for the day (unable to do anything), extreme exhaustion, severe headache, muscle pain, sweating, joint pain were resolved with sequelae on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Itch on upper chest started around 7:00 pm on 02/0221.  Itching spread to arms and torso that night.  Rash appeared in spots. No other symptoms.  Took one (1) Benadryl 25mg that night. Still have spots of rash and itching; also on thighs and back.  Aggravating enough to take one (1) Benadryl tablet every 4 hours.  No other symptoms.  Notified my Primary Care Physician and registered for V-safe this morning.
brief episode of bilateral upper extremity weakness and numbness.   symptoms completely resolved after approximately 10-15 minutes. Completely asymptomatic since this event.
Swelling, redness & itching at injection site. Relieved with BENADRYL. No further action necessary.
I suffered a stroke 13 days post booster.  Had episode of double vision for 3 hours. I went to the ER after the first hour. CT scans were negative but MRI showed an acure small infarct in the left occipital lobe.
Today my arm started feeling sore, g warm and itchy at vaccine site. It had a red whelp about the size of a half dollar.
fatigue, muscle aches, low blood sugar, chest pain, numbness in the right arm, headache, nausea, decreased appetite
This initial spontaneous case, received on 27-Oct-2017, reported by other-health professional and concerns a female patient of unspecified age. On 27-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose, route of administration, anatomical location, batch number, expiry date: not reported). On 27-Oct-2017, while injecting the vaccine, the nurse splashed the vaccine in her eye. The patient washed her eye and she did not experienced any side effects. At the time of this report, the outcome of the events was not reported.
Patient said her arm swelled to the size of a tennis ball, was swollen all around her arm with intense pain. She also had a rash and a fever of 100 degrees for at least 3 days. The pain was under her arm too.
Patient complained of tightness and pain in his chest, went to the clinic at the Hospital on 15 Mar 09.  The clinic then transferred him to another hospital in where he was kept under observation for two days.  We have not yet received the paperwork from hospital as they have not processed the release of information request yet so we do not know the diagnosis from there. 3/24/09 Received hospital medical records of 3/16-3/17//2009. FINAL DX: myopericarditis Records reveal patient experienced intermittent chest pain x approx 2 days & 1 day which increased, tenderness at injection sites, left axillary pain.  Seen in outlying ER where EKG & cardiac enzymes were abnormal & transferred to higher level of care. Cardio consult done.  Tx w/ASA.  Remained stable, pain decreased & d/c to home w/Cardio f/u.
Moderna COVID-19 Vaccine EUA  12/31-30 minutes after vaccine, headache, lightheaded, hot flashes (all day) 1/1- headache, nauseated, chills, lower back pain (all day) 1/2-headache, hot flashes (all day) 1/3-headache (all day) 1/4-headache (all day) 1/5-mild headache   took NSAIDS and Acetaminophen everyday, all day long- no headache relief
Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated at a hospital for vesicular outbreaks, which were diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-year-old patient of unknown gender. On 11-MAY-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Abrupt onset of ataxia evening of 4/8/10 --> fever occurred 2 hrs after onset of ataxia - office visit 4/9/10 -> ataxia and fever noted -> W/u at ER negative, CSF negative, lab normal.
Within 24 hours after receiving Moderna COVID Vaccine, started with headache, fatigue, chills & fever on 6/23/2021 in the afternoon. Took a shower, checked temporal temperature 101 - 102 F, took 2 tablets of Tylenol. Ate dinner, laid down for several hours with ice pack on head (for a few minutes). Awoke around 9:30 PM to go to bed, was shaking uncontrollably, shivering, chills & checked temporal temperature 105.3 F. Rechecked within 2-3 minutes with digital oral thermometer, 104.3 F. Took 2 tablets of Tylenol, a tepid bath, laid back in bed with ice pack on head, cold compress on back of neck. Rechecked temperature about 15 minutes later, 102.5 F temporal, shivering/shakes were lessoning.
Headache and vomiting (4 times) the day after the injection (Tuesday) - injection was Monday morning - symptoms happened at school around lunch time 12.00 PM on the Tuesday - student was sent home to monitor - no more vomiting happened after that - student is kept home on Wednesday for monitoring
Vaccinated: 10:25AM Reaction: 10:35AM 10 minutes after receiving 2nd dose Pfizer, pt reported pruritus across back, left side neck, and sternum. Pt noted "it's not severe" with no hives noted at 10:45AM.  Vitals: 115/81, 95, 16  Patient was given 50mg of Benadryl at 10:50AM with patient reporting feeling better at 11:05AM. Patient was released with husband who will drive her home. Advised patient to call ER or go to express care if any further issues.
Pt received a vaccination for combined Hep-A and Hep-B in preparation for a trip to China. Typical herpes zoster developed in the same arm, 14 days later.