chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; little bit of upset stomach; This case was reported by a consumer via call center representative and described the occurrence of nausea in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd June 2020, the patient received the 2nd dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced nausea and upset stomach. On an unknown date, the outcome of the nausea and upset stomach were unknown.   It was unknown if the reporter considered the nausea and upset stomach to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient expereinced nausea and a little bit of upset stomach. The reporter wanted to know how long these side effects would last. The reporter consented to follow up was not provided. Customer had to disconnect from call and did not provide additional details. Lot and expiration date unknowm. Injection site information unknown
diagnosis of Bell's Palsy; This spontaneous case was reported by a non-health professional and describes the occurrence of BELL'S PALSY (diagnosis of Bell's Palsy) in a 60-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (diagnosis of Bell's Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (diagnosis of Bell's Palsy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatments were provided.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
7-10 days after receiving my second COVID19 vaccine, I noticed an increase in loudness and duration of my pre-existing mild tinnitus. The noise was louder and was present 24 hours a day, whereas before it was intermittent, mild, and I was rarely aware of it.
Developed Tinnitus (constant high pitch ringing) in both ears about a week after first dose.
As the soreness was fading away the itching started from my right shoulder to my upper back across my left shoulder then to my forearm on both sides. Then a little on my abdomen and my back was just as bad but the visible rash wasn?t as bad on my lower back. The I had rash appear on my butt, thigh, and behind my knee. I had less visible hives on my legs it wasn?t as intense as the rest of the irrated areas.  I suffered from October 27 until November 7, which is when I went to see my doctor. The doctor did believe that the shot caused all of this. I was given a solumedrol injection and prescribed a Medrol dose pack. I started to feel much better by November 8, before I couldn?t sit too long without itching and irritation. Today November 9 I have no itching at all.
Narrative:  Patient admitted from nursing home to the floor due to testing COVID+ on BINAX and PCR. Patient was asymptomatic at the time of admission.
2nd vaccine , felt like I got punched in the arm with a raised knuckle , as I stood I was started to faint  ,sat in the closest chair and everything started tingling like a big head rush and within a minute it subsided , allow I didn't pass out had I had to walk  any further I believe I would have .  Also the next day I had fever and body aches and systems lasted one day
pt c/o rash covering entire body; pt recv vax 15JAN98;MD concluded had MMR rxn;temp was 99.1R;no other sx noted;pt was currently taking septra for ear infect;
Erythematous, slightly raised, somewhat painful (like a sunburn) splotchy rash over the neck, scalp, and trunk. Began approximately 36hrs post-injection and 24hrs after a post-injection fever of 100.3F. Rash lasted approximately 24 hours before fading. After the rash faded, areas where the rash was present were itchy for 72hrs afterwards. No specific treatment applied. A similar rash has occurred after viral fevers in the past (such as the flu or norovirus), but never this severe and never following vaccination.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 54-year-old female patient who received BOOSTRIX. Co-suspect products included Flu Seasonal TIV Dresden (Influenza vaccine unspecified). Concomitant products included hydrocodone. On 30th September 2016, the patient received BOOSTRIX and Influenza vaccine unspecified. On 1st October 2016, 1 days after receiving BOOSTRIX and Influenza vaccine unspecified, the patient experienced fatigue, fever and headache. On an unknown date, the outcome of the fatigue, fever and headache were not recovered/no resolved. The reporter considered the fatigue, fever and headache to be almost certainly related to BOOSTRIX and Influenza vaccine unspecified. Additional de tails were provided as follows: This case was previously reported to a doctor. The patient received influenza vaccine and whooping cough vaccine on the same arm. The patient began to experience fatigue and low grade fever ever since receiving the vaccine. It was hurting her everyday life big time. The events had not improved after one week. The patient appeared not appreciate the advice she received from her pharmacist. The patient was seen by her by her physician and was informed to keep an eye one it and if it gets worse to go to the Emergency Department. Initially the patient had talked to a sales representative about her side effects, but at the time was not sure it was a GSK products. She called the pharmacy she received the vaccine and confirmed it was GSK vaccines. The patient for the most terrible headache that she had experienced ever in her life everyday since 6 days she got a headache that did not go away. The patient was asking whether this symptoms was common.
Patient received Hep B Vaccine. After vaccine was given, Medical Assistant documenting vaccine noticed that it was expired. Vaccine expired 09.22.2021 and was administered 09.30.2021.
Chills, headache, cough.  Seen 11/24/10 with bronchitis.  He quit smoking 4 years ago, but wife still smokes.  I Rx'd doxycycline, benzonatate, and Hycodan.
Headache, Myalgia, Arthralgia, sore ness at injection site, chills Narrative:
pt recvd vax; 3 days later, devel pain & neuropathy in lt arm; resolved completely by 24dec94; dx:degenerative w/ perintendinus calcification;renin,plasma 4.10H;high renin hypertension >3.2;cholesterol,serum 245 H;iron binding capacity 397H
Pt says she has had diarrhea the entire day.  She never has diarrhea before.
it hurts; arm was sore; This case was reported by a consumer and described the occurrence of pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain, and pain in arm. On an unknown date, the outcome of the pain was unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain and pain in arm to be related to Shingles vaccine.  Additional details were provided as the case was reported by the patient herself. The age at vaccination was not reported. The patient received the 1st dose of Shingles vaccine and the patient stated that the downside of the shot it hurts. The patient also stated that arm was sore for 3 days, but she rather had a sore arm than the shingles. The patient stated that her 2nd shot was due in October. The follow-up would not possible as no contact details were available.
headache, mild body aches, fatigue, mental fogginess day and a half after vaccination
I had a fetal demise at 17 weeks. When the baby was born he measured 14-15 weeks gestation...which was how far along I was when I received the vaccine. I have two healthy daughters.
I started feeling very ill the evening of my second Pfizer shot. My symptoms included headache, muscle pain, chills, nausea, vomiting and fatigue. I felt very unwell for 4 days. By Feb 1st, I started to feel better.
aches; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had experienced aches post vaccination. The patient asked what could I take to help with aches. The patient asked whether to take Tylenol or Advil. The patient would contact the pharmacy.
Gross hematuria Hematuria, unspecified type Flank pain Hypo kale Mia Factor V Leiden
This spontaneous report as received from a healthcare worker refers to a 20 months old patient. No information regarding the patient's medical history was provided. On 08-JAN-2013 the patient was vaccinated with ZOSTAVAX instead of VARIVAX due to a human error. No adverse effects were reported. No other co-suspects were reported. No concomitant medications were reported. No outcome was reported. Additional information has been requested.
Patient with  previous high level recovered antibodies present, experienced fever of 101, chills, fatigue, loss of appetite, night sweats, pain at injection site. Several days of bed rest.
13APR94 @ 230PM started c/o h/a, vomited 3PM, took nap from 3-6PM; woke up @ 6PM c/o lat arm pain; lt arm sl swollen w/o redness; t101; exp n&v;
This spontaneous report was received from a healthcare worker refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ, lot # K024700, expiry date 30-JUL-2016, (dose, frequency and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of five reports received from the same reporter. Additional information has been requested.
fairly mild dizziness; tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (fairly mild dizziness) and FATIGUE (tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-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 FATIGUE (tired). On 05-Feb-2021, the patient experienced DIZZINESS (fairly mild dizziness). On 02-Feb-2021, FATIGUE (tired) had resolved. On 07-Feb-2021, DIZZINESS (fairly mild dizziness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided.  No treatment medications provided by the reporter.   Patient received the second vaccination 3 weeks later with no AE    Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up received provided event outcome as recovered and 2nd dose details.
Numbness in legs no felling itchy, numbness in shoulders, face, head, and weakness. Told my Dr he recommended not O2 hemoglobin elevated CBC elevated. No reason yet.
Pentacel was not mixed with manufacture diluent. It was mixed with saline.  NO adverse reaction
Patient was brought to the ER via ambulance for complaints of altered mental status and respiratory distress.  Patient was found to have covid 19 and was transferred to local Medical Center to the care of Medical Services Group.
04/26/99- received anthrax #4- burning sensation in the injection area for 10 mins. 11/01/99- received anthrax #5- burning sensation in the injection area for 30 mins. 06/06/00- received anthrax #6- burning sensation in the injection area for 1 hr.- "whole arm burned from the injection area to the tips of my fingers." 07/06/00- noticed a "raised white areas like a mosquito bite" at the injection site- and "every couple of weeks" for the past 3 years, he has noticed the "lump(s)" reappearing in the "always same spot" on the injection site- the size and number of the lump(s) varies from time to time- the lump(s) "usually goes away within 1-3 hours."  A copy of the patient's clinical summary sent to VAERS via FedEx on 09/09/03.
Developed localized reaction on day 8 after 1st injection - had no location reaction prior. No intervention needed.  28 weeks gestation at time of vaccine and due date 3/10/21.
Pt rec'd shot father noted red swollen ear lobe; during noc pt awoke & had several red raised lesions on face & extremities; Seen by MD-typical urticarica rash;
Staff member received first COVID vaccine dose at FMF, Moderna manufacturer.  staff member came to auditorium today for second dose which was administered, manufacturer is Pfizer.  Staff member badge did not scan, so paper form was filled out. Administrator emphasized that staff member was going to receive his second dose of the Pfizer and the staff member said "Yes".  The staff member did not let the administrator know he received the Moderna for the first dose.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-JUN-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-APR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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 expense, and pain and suffering, and other damages. Additional information has been requested.
pt recv vax 20NOV97 & 4DEC97 pt devel a rash that looked like measles;
Redness and itching at injection site. Redness measured 42mm 12 days post vaccination.
I first started having problems about five mins after my shot. It was very hard to breathe and every movement caused a sharp pain in my center back to occur my stomach hurt and I felt achy. I still have pain in my center back. I seen a chiropractor immediately after these symptoms. Still experiencing aches.
Felt a very deep ache throughout entitre body; Tired; Every bone in  body hurt; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Every bone in  body hurt), PAIN (Felt a very deep ache throughout entitre body) and FATIGUE (Tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic back pain (2 major back surgeries.), Hypothyroidism, Scleroderma (Autoimmune disease.), Pustular psoriasis (Autoimmune disease.) and Drug allergy (Allergic to penicillin, e-mycin, Compazine, dynastat, breo.). Concomitant products included LEVOTHYROXINE, MORPHINE SULFATE, PREGABALIN, TIMOLOL, LATANOPROST, KETOROLAC, VITAMIN C [ASCORBIC ACID], CALCIUM and MINERALS NOS, VITAMINS NOS (CENTRUM BALANCE) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BONE PAIN (Every bone in  body hurt). On 05-Feb-2021, the patient experienced PAIN (Felt a very deep ache throughout entitre body) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 05-Feb-2021, BONE PAIN (Every bone in  body hurt) had resolved. At the time of the report, PAIN (Felt a very deep ache throughout entitre body) and FATIGUE (Tired) had resolved. Not Provided          Treatment information included Blood pressure medication and  took Tylenol throughout the day evening, every 4 hours plus. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.   This case was linked to MOD-2021-005455, US-MODERNATX, INC.-MOD-2021-005455 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24-May-2021 updated patient address, demographics, concomitant medications and add events.; Sender's Comments:  MOD-2021-005455:1st dose of vaccine US-MODERNATX, INC.-MOD-2021-005455:DOSE 2
24 hours after shot, headache, mild left arm soreness. Over next several days, very mild transient dizzy spells, mild headache, feeling ?off?...brain fog....approximately 9:30 am 2/26/21, walked into a store and after getting 1/2 way to back of store, had sudden onset distorted vision...not dizziness, distorted vision...had to ask for a chair as I felt like I was going to pass out...distorted vision lasted approx 6-8 minutes, along with slight nausea. Pulse was 68 and regular.  Went to Dr, EKG normal, blood sugar, orthostatics Normal, Pulse ox 98%,.  Went home to lie down. Still having occasional fleeting ?dizzy? spells and fatigue.
she initially didnt feel anything and the pain wasnt even that bad; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 14Jul2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 27Jun2021 as dose 1, single (Lot number: EW0181) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.The patient did not receive any other vaccines within four weeks prior to the vaccination. The following information was reported: PAIN (non-serious), outcome "unknown", described as "she initially didnt feel anything and the pain wasnt even that bad". Therapeutic measures were not taken as a result of pain.  Additional information: Caller was a 68 year-old female who was calling about the Pfizer Covid-19 vaccine and Paxlovid. Caller reports that she had a reaction last year to first two dose of the Pfizer Covid-19 vaccine. Caller reports that she was reading about the severe reactions people were having to the Pfizer Covid-19 vaccine and thinks it was the polyethylene glycol in the Pfizer Covid-19 vaccine that caused these reactions. Caller reports there were issues with the Pfizer Covid-19 vaccine and that Pfizer should learn from other peoples reactions in regards to Covid-19 vaccines. Caller was asking if the ingredients for the Omnicron-based vaccines were the same as for the Pfizer Covid-19 vaccine. Also, patient stated to be honest, when she had the shots, she initially didn't feel anything and the pain wasn't even that bad. She was actually one of those people who don't do medications. Does a lot of juice and exercises, was a very healthy person. The AE(s) did not require a visit to Emergency Room and Physician Office. The patient does not even get flu vaccine. Had not had flu vaccine since 70's when swine flu was out.
I had fever for two three days, arm pain and had problems to breathe. I had to go to the ER.
Employee woke up at about midnight on 1/9/2021 with intractable nausea vomiting with continuous bout of diarrhea.  Diarrhea lasted unitl 8-9 am and intractable vomiting until 9 pm  (18-20 hrs).
My due date was 5/26/2021. On 2/28/2021 I started having cramps/contractions, and they continued on and off for 8 days. On day 4 I saw a doctor who checked my cervix, which was closed. On the 8th day they we?re definitely contractions. At 2pm I drove myself to the hospital, arrived at 2:40. My water broke, cervix dilated at 3cm, I had a prolapsed cord and an emergency c section. My son was born at 24 weeks.  I do have a history of preterm labor, but my first son was born at 30 weeks and the cramps didn?t happen like they did this time.
-Tingling sensation after giving shot -BP -150/96 -Tingling lips and tongue
Moderna Covid-19 Vaccine EUA Muscle pain,headache,redness where vaccine was applied,nausea,
13mins post vaccination pt c/o flushing, feeling shaky and hot all over.  Pt states that she's a very anxious person. Vitals: BP 149/84, HR 94, RR 16, Temp 99.7 OT Sat 100% RA Pt stayed for 30 mins observation.  Pt stable and released for the vaccination site.
My children were given an unknown concentrated dose of Covid-19 Vaccine/Second dose vaccine administered improperly; administered 1.5ml Pediatric Pfizer Covid 19 Vaccine; sore arm; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 02Feb2022 (Lot number: FL0007) at the age of 11 years as dose 2, 1.5 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, lot: FL8094, Route of administration: one of arms, not sure which arm), administration date: 12Jan2022, when the patient was 10 years old, for COVID-19 Immunization. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious) with onset 02Feb2022, outcome "unknown", described as "My children were given an unknown concentrated dose of Covid-19 Vaccine/Second dose vaccine administered improperly"; OVERDOSE (non-serious) with onset 02Feb2022, outcome "unknown", described as "administered 1.5ml Pediatric Pfizer Covid 19 Vaccine"; PAIN IN EXTREMITY (non-serious) with onset 02Feb2022, outcome "recovered" (07Feb2022), described as "sore arm"; ILLNESS (non-serious) with onset 02Feb2022, outcome "recovered" (07Feb2022), described as "sick".  Additional information included: The caller was a consumer who called Pfizer earlier and was not able to complete everything because the caller was driving. The call was regarding both the Adult Pfizer Covid 19 Vaccine and the Pediatric Pfizer Covid 19 Vaccine. The second dose Pfizer Covid 19 Vaccine was administered improperly to the patients. The kids were okay a week later but were sick. The patient had the least amount of reaction after receiving second dose Pediatric Pfizer Covid 19 Vaccine. The patient had a sore arm. second dose vaccine was administered improperly: The patient was administered an excessive amount of fluid in the deltoid, was administered 1.5ml Pediatric Pfizer Covid 19 Vaccine in the deltoid, not 0.3ml or 0.2ml as necessary, a lot. sore arm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200228960 Same reporter/drug/AE, different patient;US-PFIZER INC-202200229781 Same reporter/drug/AE, different patient