chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune deficiency syndrome and Cancer. Concomitant products included AZATHIOPRINE for Autoimmune deficiency syndrome, RITUXIMAB (RITUXAN) for Cancer.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            The patient is on an immunisuppressant medicination, the caller has been taking Aziathioprine 50mg on one day and  increased dosage of Aziathioprine to 100mg the next day for autoimmune deficiency.  No treatment medications were reported.   This case was linked to MOD-2021-194120 (Patient Link).
arm soreness; This is a spontaneous report from a contactable nurse for brother. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant mediations not provided. The patient didn't experience anything else other than the soreness, arm soreness but didn't experience those symptoms (further clarification unknown). The outcome of event was not reported.   Information about lot/batch number has been requested.
Severe lower back pain (mainly at left waist) started on 10/3/2021 and still won?t go away as of today 10/13/2021.  Very painful to lie down or get up or turn body around, and very difficult to put on pants and socks as it caused big pain when bending over  my body. Started to take Aleve pain reliever since 10/3. Dr prescribed Mobic 15mg Tab.
Not adverse at all in fact I typically use inhaler 3 times day, for following 4 days did not require at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 05Apr2021 12:00 (Lot number: ER8734) at the age of 63 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Low Thyroid" (unspecified if ongoing). Concomitant medication(s) included: PLAVIX; SYNTHROID; LIPTOR [ATORVASTATIN]. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 Immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 05Apr2021 11:45, outcome "unknown", described as "Not adverse at all in fact I typically use inhaler 3 times day, for following 4 days did not require at all".  Additional information: The patient was not pregnant at time of vaccination. The patient had no COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks. Clinical course: Not adverse at all in fact, patient typically used inhaler 3 times day, for following 4 days did not require at all, and know ones with arthritis, that next day after shot, no swelling, tightness or pain.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021457421 Same reporter, suspect drug and event; different patient
This spontaneous report as received from a certified medical assistant (CMA) concerning an unspecified number of patients (gender and age unspecified) which reported that the patients received improperly doses of GARDASIL (dose, route and lot # unspecified) between 16-JUN-2014 and 13-JUL-2014. No adverse symptoms reported. This is one of several reports from the same source.  Additional information has been requested.
The patient began to experience lightheadedness and nausea within a few minutes of the vaccine administration. She did not experience this with either of the other two doses. She noted she had not eaten in over 12 hours.
feeling slightly weak; feeling unwell; felt as if she is getting the flu or in the beginning stages of the flu; tired; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL3247), via an unspecified route of administration on 21Jan2021 20:00 at single dose for COVID-19 immunization. The patient's medical history included uses a walker on a regular basis for spinal stenosis. Concomitant medications were not reported. Patient received first dose of Pfizer COVID vaccine on 21Jan2021 around 8pm, at the vaccination site she was tired and was given a chocolate chip cookie and felt better. On 22Jan2021 morning she was feeling slightly weak nothing violent she is just feeling unwell. She generally feels weak, but said this is hard to explain. She felt as if she is getting the flu or in the beginning stages of the flu. Patient does not have a fever. Generally doesn't get reactions to the flu shot or pneumonia shot, that is very minor. The outcome of tired was recovering, of other events was unknown. Patient would like to know if her symptoms are to be expected after receiving the first dose of the vaccine and how long will her symptoms last, what to do about her symptoms.
Swelling of lips and face within 2 hours of vaccine.  Treated with Benadryl and two doses of po steroids, given 24hrs apart.
PASSED AWAY; CLOTS; This spontaneous report received from a patient through social media via a company representative concerned two patients of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have history of drug abuse or illicit drug usage. Both had no health issues and were under 50. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) dose not reported, 01 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  Reporter stated that 2 friends through clots and passed from the single shot vaccine. On an unspecified date, the patient died from unknown cause of death. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of clots was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20220256761-COVID-19 VACCINE AD26.COV2.S-Passed away,Clots. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Large erythema of (L) thigh. 6 cm radius. KEFLEX 250/5mL, 3/4 tsp PO QID x 5 days ordered by PA-C.
fatigued, sleepy, couoldnt eat, leg swollen, right footnumb, right leg impaired
seen in ER 29Oct /c lower extremity weakness, pain, both legs & back since 13Oct-was seen in another ER (X-rays-neg). c/o inability to walk
Tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid-19) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced COVID-19 (Tested positive for covid-19). The patient was treated with BAMLANIVIMAB for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, SARS-CoV-2 test: covid-19 (Positive) COVID-19.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications reported.
PATIENT LEFT THE PHARMACY AFTER STATING SHE FELT FINE TO THE IMMUNIZER. SHE LATER FAINTED IN THE PARKING LOT AND THE CLINIC NURSE WAS CALLED AND CHECKED ON HER. WE DID NOT FIND OUT UNTIL HER HUSBAND BROUGHT IN A RX FOR HER THAT ANYTHING OUT OF THE ORDINARY HAD HAPPENED. HE SAID SHE WAS FEELING BETTER BUT STILL NAUSOUS AND THAT SHE HAS A FEAR OF NEEDLES.
This spontaneous report was received from a nurse refers to a 2 years old patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dosage schedule, route, anatomical location, lot number and expiration date were not reported). On 10-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 days before she turned 2 years old(administered to patient of inappropriate age). No adverse effects. The outcome of product administered to patient of inappropriate age and no adverse event were unknown.
This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patients were vaccinated with an improperly stored doses of ROTATEQ, orally, lot number M019706 with expiration date 24-OCT-2017, (dose was not reported) for prophylaxis. On 03-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 9.5 hours; Also on these dates from 04-JAN-2017 to 11-JAN-2017; 13-JAN-2017, from 16-JAN-2017 to 20-JAN-2017; from 23-JAN-2017 to 27-JAN-2017; 30-JAN-2017 and 31-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 10 hours each day; all of them in the first cycle. In addition on 12-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 10.5 hours in the first cycle. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA007376: US-009507513-1702USA007377: US-009507513-1702USA007375:
Headache, nausea, sore arm for 3 days following shot. A week after shot, developed itchy rash at injection site
Pain in arm at sight of injection causing pain and patient is barely able to lift or move arm; thinks it was injected too high on arm
Information has been received from a physician concerning a 3-year-old male with coeliac disease who in 2005 (2 years ago) was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included montelukast sodium (MSD) and Nasonex. On an unspecified date the patient developed chickenpox. The patient sought medical attention via an office visit with a physician. At the time of the report the patient's status was recovering. A product quality complaint was not involved. Follow-up information indicated "we can not remember which patient it was ". Additional information is not expected.
Severe burning in the chest, like on fire, then very weak in the knees...Made it to my car & rested a while, then it passed, but was weak rest of day..
I have gone thru menopause and haven't had a menstrual cycle in about 15 years and have had no female issues ever.  On 5/5/21 I had severe cramps and then heavy spotting.  It lasted just a few hours.  Today on 5/7 I'm having heavy cramping.
10 minutes after vaccine administration, patient experienced nausea, dizziness and abdominal discomfort.
Patient complaint of nose bleeding and felt like drunk the next day when she woke up in the morning.  However, after talked to Ms at 5pm on 09/15/09, she said she is OK and feels normal now:  no more nose bleeding, no more feeling like drunk.  Patient said she may be lack of sleep the day before got shingles vaccine.
can take the second dose of the Moderna Covid19 vaccine after the 28 days mark, because they missed their appointment; Felt chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Felt chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (can take the second dose of the Moderna Covid19 vaccine after the 28 days mark, because they missed their appointment) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced CHILLS (Felt chills). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (can take the second dose of the Moderna Covid19 vaccine after the 28 days mark, because they missed their appointment). At the time of the report, CHILLS (Felt chills) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (can take the second dose of the Moderna Covid19 vaccine after the 28 days mark, because they missed their appointment) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment information was not provided.
After Tdap was given patient was asked to wait in office. After 5-7 minutes of receiving the shot patient felt very shaky and dizzy. BP 140/90, HR 94. Monitored in the office for 30 min then sent to ER.
I'm having problems please call me; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (I'm having problems please call me) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (I'm having problems please call me). At the time of the report, ADVERSE EVENT (I'm having problems please call me) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Mild, Additional Details: Language barrier -
The patient  was vaccinated by MA after being signed off by the provider PA- number of doses was not mentioned by the pt in the vaccine consent form and the vaccination card was not presented to the MA prior to vaccination. After the shot , the pt gave the vaccine card to MA to record the LOT and expiry date and that is when she realized that the pt had received a Moderna bivalent shot on 9/23/2022. Both the provider and pt was informed about the medication error. The pt was asked to contact our clinic should she have any adverse reaction or does not feel comfortable, if can't reach us in the clinic then to go to ER immediately. i followed up with the pt today and doing good.
his chest is all red, his chest and his face and his forehead all like burning red and feels very hot; his face got all red, his chest is all red, his chest and his face and his forehead all like burning red and feels very hot; This is a spontaneous report from a contactable consumer Submitted by Call Center. This consumer reported for the patient(son). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number, expiration date and NDC number were unknown) via an unspecified route of administration, administered on 01Jul2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that my son took the Pfizer vaccine 4 days ago, yesterday (04Jul2021) his face got all red, his chest is all red, his chest and his face and his forehead all like burning red and feels very hot, he has no fever, he has no other symptoms so burning is this is 4 days after the vaccine and questioned have you heard anything like that form your vaccine? It was white like it was retaining something. Vital signs were normal. When we take Benadryl it seemed to help. The patient took treatment for all the events. The outcome of all the events was unknown.   Information about lot/batch number has been requested.
Patient reported to the county & PHN on 12/09/21 at 2:30PM- that beginning the night of her vaccination she had pain in her arm.  This pain began to radiate into the right shoulder the following day. Patient reported numbness/loss of feeling in her right arm the day after her vaccination. Patient feels like the numbness/tingling is going into the left arm-which began a few days after that. Patient said "it feels like it's getting into my nerves." See CONTINUATION PAGE.
Myalgia, Arthralgia, Fever, Diarrhea & NauseaVomiting Narrative:
pt recv 2 dose of vax 30OCT95 & 3JAN96 & 9APR96 pt exp failure to seroconvert (ELISA 0.52);
Patient admitted on 1/29/2022 for IOL for preeclmapsia with severe features.  Her labor course progressed without complication. She had an uncomplicated SVD of a viable female infant weighing 4 # 15 oz.
Petechiael rash, nausea/vomiting and subconjunctival hemorrhage
Got flu shot and PNEUMOVAX 9/20/13. Patient developed fever (104) degrees, developed large red areas at site of injections and also hives which were tender and itchy. Took BENADRYL, getting better - seen in office on 9/23/13. Pt called today (9/25/13) pt reports doing fine.
Shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2019, the patient received the 1st dose of Shingrix. In October 2019, 3 weeks 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 provided as follows: The RN called in to inquire on how to proceed with Shingrix series. The patient broke out with Shingles 3 weeks after receiving 1st dose of Shingrix. The reporter did not consented to follow-up.
This happens to me after getting blood drawn but I was not expecting to happen after a vaccine since it has never happed before with a vaccine. 3 to 5 minutes after getting injected I started to feel lightheaded and then my vision started to blur because I was going to faint. I was taken care of by the pharmacists, they told me to stay still but that actually causes a person to faint so I moved my limbs to help blood flow and avoid fainting. The pharmacists wouldn't let me lay down and that made things worse because if I lay down I would feel better. After about 8 to 10 minutes of this I puked and I started to feel better. For the rest of the day I felt very weak and had to be laying down. 3 hours after the injection my left arm got extremely sore. The day after I was still weak but a bit better than the day before.  Now it has been 6 days since the vaccine and I have gotten a huge cold sore which was a rare instance for me. I know there are case reports of people developing herpes zoster after vaccination with tozinameran. The vaccine is supposed to boost our immune system and a cold sore is indication of a weak immune system.
Information was received from a lawyer regarding a case in litigation concerning a male plaintiff of unspecified age. It was claimed this plaintiff suffered personal injuries and damages as a direct and proximate result of being inoculated with ZOSTAVAX). The plaintiff was inoculated with ZOSTAVAX, administered by a physician, on or about 03-JUL-2012 (dosage, route and site of administration unspecified) as recommended for routine adult health maintenance for the prevention of shingles.  It was claimed that the vaccine did not prevent shingles as intended, but rather caused the plaintiff to contract a persistent strain of herpes zoster.  On or about 05-AUG-2015 the plaintiff was treated by a nurse practitioner for a vesicular outbreak that was diagnosed as severe shingles.  On or about 04-APR-2016 the patient was treated by the nurse practitioner at the offices of the physician who had administered ZOSTAVAX, for ongoing and worsening symptoms, which was then diagnosed as post-herpetic neuralgia.  The plaintiff was prescribed acyclovir (VALTREX), acyclovir, lidocaine, amitriptyline, gabapentin and tramadol for ongoing treatment of his unmanaged persistent symptoms.  As a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment.  As a further proximate result, plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
Left thigh became red from knee to upper thigh and back of thigh. Faded completely within 1/2 hour.
Severe rigors, myalgia, fevers, and body aches. No rash or allergic reaction.
Pain at injection site upon administration. Sore arm, unable to lay on arm for a few days. Redness (6x4inch area) and itching around injection site 4 days post injection.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 02-AUG-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number and expiry date were reported as H014561 and 21-MAR-2014 respectively, dose and route unspecified) which was not supported by stability data. It was exposed to five cycles of a low temperature range from 32 degrees Fahrenheit (F) to 34 degrees Fahrenheit (F) for a total time of 96 hours. No concomitant therapy was reported. No adverse effects were reported. This is one of the two reports from the same source. Additional information has been requested.
This male subject was enrolled in the prophylactic open study 110870 (MenACWY-TT-057). On 12 June 2008 and 07 August 2008, he received the 1st and 2nd dose of HIB-MENCYT-TT, IM L thigh) and PEDIARIX, IM R thigh. On 29 October 2008, 83 days after the 2nd dose of PEDIARIX, 83 days after the 2nd dose of HIB-MENCY-TT, this six-month-old subject developed anemia, bronchiolitis and acute otitis media. The subject was hospitalised and the event was clinically significant (or requiring intervention). The subject was treated with ceftriaxone sodium, salbutamol sulphate and amoxicillin trihydrate. The events improved on an unspecified date. The investigator considered that there was a reasonable possibility that anemia may have been caused by PEDIARIX and HIB-MENCY-TT whereas there was no reasonable possibility that the bronchiolitis and acute otitis media may have been caused by PEDIARIX and HIB-MENCY-TT. Investigator Comments: Patient was admitted in Medical Center on 29Oct2008 for Bronchiolitis and Ear Infection. The CBC on that was taken showed anemia and leukocytosis. The Chest X-Ray was negative and RSV testing was positive. The Patient was given ROCEPHIN IV and Albuterol Nebs every 4 hours. The patient was discharged home that day after with orders to follow-up with her pediatrician.