chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a slight headache all day today; head felt like it was just heavy like heavy head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: HEAD DISCOMFORT (non-serious) with onset Nov2022, outcome "unknown", described as "head felt like it was just heavy like heavy head"; HEADACHE (non-serious) with onset 16Nov2022, outcome "unknown", described as "Had a slight headache all day today".  Additional information: Consumer stated, "Well, I want to know if this is normal, I had a slight headache all day today (16Nov2022) and then my head felt like it was just heavy like heavy head." Product Name: Consumer stated, "Yes, I got my shot on Monday. Yes the omicron or something." When probed to clarify if consumer has any query: Consumer stated, "That is what I have a questions is that, was it normal if I had a, I mean like a heavy head." Consumer stated, "So is that normal? I am asking you if is it normal because I got this (Pfizer COVID-19 Vaccine) on Monday and it should be wearing off and I should be doing good.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt had injection just below acromion, inappropriate site. Likely into subdeltoid bursa. Developed severe pain w/ AROM of left shoulder a few hours later that persisted into the next day .Suspect bursitis.
This spontaneous report was received from a patient's wife, who is also a physician refers to her husband of unknown age. Medical history was not reported. On 18-JUN-2014 the patient was vaccinated with ZOSTAVAX vial 19,400 unit 1 standard package vial of 1, intradermal, dosage, lot number, expiration date were not reported. Concomitant therapy was not reported. The reporter informed that she believed that the ZOSTAVAX given 18-JUN-2014 may have been administered to the patient intradermal. She also reported that injection was painful to the patient, the patient developed wheal measuring 3 inches by 2 inches along with thickening to the injection site since 20-JUN-2014, the events remains ongoing. It was unknown if the patient sought medical attention. The patient's outcome with the event was not recovered. Additional information has been requested.
A non-serious, spontaneous report of hives over entire body was received from a nurse, concerning a 36-month-old male subsequent to FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 50 months of age for FLUMIST.  Neither relevant medical history nor concomitant medications have been reported for this patient.  The patient received FLUMIST on 30-Oct-2008.  Within a few hours the child developed hives over his entire body.  DIPHENHYDRAMINE liquid was administered and the hives cleared.
On 3/18 Started out with arm and shoulder feeling hot.  Then Excruciating pain in shoulder and all down the arm from 3/19 and still continuing today 3/27. Took Tylenol and used ice on shoulder and arm. Had a massage and stretching done on 3/23 didn?t help much.   Contacted my doctors office on 3/23 and have an appointment for 3/31. The symptoms I?m feeling is that of SIRVA.   Went to urgent care on 3/26 and was told that ?that is a symptom of the vaccine, give it another day?.  Told them it was over a week and the pain I?m feeling is nerve pain. I was told there was nothing they can do for me there. Still feeling the pain today.  Still icing and using  Voltaren gel to help with inflammation.
Symptoms started early morning on 11-19-13 with arm pain, then neck pain, back pain and leg pain. Symptoms quickly became worse. 11-20-2013 He was diagnosed with Cervical Epidural Hematoma of the spine.
My rib bones, the ligaments were inflamed, and it was painful when I bent forward. I had an X-Ray. But the X-Ray was done too late, and the inflammation had healed. I had a bone scan first and that doctor requested and X-Ray. The ligaments in my knees are acting up and it felt like my knees came apart. It was really, painful. I had to wear my knee brace. My alkaline phosphates are too high, and I do not have an explanation for this yet. I have had not treatment.
shingles; she presented a rash on her left hand; This is a spontaneous report received from a contactable consumer (patient).  A female consumer of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Apr2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Mar2021 for COVID-19 immunisation. The patient presented a rash on her left hand since 18Apr2021 and she went to urgent care, where they prescribed viral medication for shingles. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Had injured shoulder blade /arm 5 years ago... The same area with pain since shot ( Right upper back/ shoulder blade area with pain that is now going  up to neck area on the right side.  also upper right arm fells heavy).. Just made an apt with acupuncturist that I will see on 3/21/2022.  Plan to make an apt with a MD next week
Left arm where needle went in is all pink, very warm, kind of swollen, sore and itchy; Left arm where needle went in is all pink, very warm, kind of swollen, sore and itchy; Left arm where needle went in is all pink, very warm, kind of swollen, sore and itchy; Left arm where needle went in is all pink, very warm, kind of swollen, sore and itchy; Left arm where needle went in is all pink, very warm, kind of swollen, sore and itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 12:30 (Lot number: EN6200) at the age of 85 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot number: EL3246, /Expiry: Unknown, this information is not on the CDC vaccine record card., Dose: Unknown strength/volume/dose injection to left arm at about 12:30., Route: Injection, Anatomical Location: Left arm), administration date: 03Feb2021, when the patient was 85 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE DISCOLOURATION (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "not recovered" and all described as "Left arm where needle went in is all pink, very warm, kind of swollen, sore and itchy". Additional information: After the Dose 2 administration around 5 days later or maybe more patient had experienced the onset of event. Event was ongoing and not getting better. Adverse event not required a visit to emergency room or physician office and hospitalization. No prior Vaccinations (within 4 weeks) (None other than first dose of Pfizer COVID-19 Vaccine). No patient medical history and no relevant tests has reported.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable Physician via Pfizer sales representative. An adolescent male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history was not reported.  There were no concomitant medications.  The patient experienced shake extremely/ body was shaking on an unspecified date with outcome of unknown.  The event lasted for about 5 minutes.
Patient describes swelling and redness in the right arm, warm to the touch with a weal that is only now getting better. She reported this today, a week later. Patient never went to the doctor, just wanted a report made on her profile.
Patient immediately vomited following vaccine administration. After mom left the clinic, she called saying that the infant had been crying nonstop for more than 3 hours following vaccination, looking as if she was in pain and very uncomfortable. Patient continued vomiting several times following administration of vaccine. The mother reported stomach gurgling, gas, and refusing to breast feed. Pt had 1 soft stool following vaccine. Doctor advised to do probiotic, mylicon, and gripe water. Told to bring to ER if symptoms continue for 1-2 hours. That night, the baby finally started to calm down with the probiotics and gripe water. The next day the infant was eating again and seemed to have improved significantly.
24 hours post vaccination c/o fever 101.4, chills, HA, malaise, nausea
Pt recv vax on 10/6/98; on 10/9/98 pt exp headache, stiff neck, right elbow discomfort x 2 wk;tx=Advil & Tylenol
On 2/28/2000, pt presented with symptoms of red, swollen and warm to touch, right upper thigh.
Pt was immunized w/HIBTITER on 27JUN91, 28AUG91 & 11DEC91 seen in office 14DEC91; pt had swollen red eye; hospitalized; eye cultured & blood cultures performed; both were positive for H. Flu; treatment included ATB;
Pt received HPV vaccine around 5pm, got up right away after shot was given, pt walked to other side of the room and per RN pt was next to the door/ wall and passed out for maybe 5 seconds 5:05pm, pt came to and was helped up to a chair where she states she felt hot and sweaty, pt was A and O x 3. I gave pt a wet paper towel for her forehead and some M and M and water, I stayed with pt for 45 mins to monitor her. Pt states she felt much better after water and M and M, was able to get up and walk without issues. I reassured mom, pt was back to baseline and further care was not need at this time but if she wanted if any other worsening s/sx to call on call MD or go to ER.
Information has been received from a consumer concerning her daughter, who lives in another country, who on 30-SEP-2005 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (manufacturer unknown). The reporter indicated that her daughter was vaccinated against "measles and rubella". She became pregnant and feels that  01-OCT-2005 was the conception date. The vaccines were given " a day or two before conception" to her daughter by the "nurse on the street" and she did not know any specifics on dosage or how they were delivered. Her daughter had since developed swollen lymph nodes and was always dizzy. There was no product quality complaint involved. Additional information has been requested.
This is a spontaneous case initially received from other health professional on 31-Jan-2019, concerning a male neonate. The patient's mother was 38-year-old female, who had no previous pregnancies. The mother had no family history of offspring and no relevant maternal and paternal medical history. The mother did not use tobacco, alcohol and illicit drugs during pregnancy. The mother's last menstrual period (LMP) date was 10-Apr-2018. The type of pregnancy was singleton. It was reported that the at an age of 38 years the mother had pregnancy which considered as advanced maternal age. The patient's mother underwent prenatal birth weight (PNBW) test (on 25-Jun-2018), non-invasive prenatal (NIPT) testing (on 10-Jul-2018), and anatomical scan (on 10-Sep-2018) which showed no congenital malformations. On 18-Oct-2018, 1-hour glucola test (as reported) was performed which showed elevated. On 23-Oct-2018, at gestation age of 28 weeks, the fetus was exposed to AFLURIA QUADRIVALENT [influenza vaccine, batch number: YF41708, route of administration: transplacental, dose, anatomical location, and expiry date: not reported] (explicitly coded as foetal exposure during pregnancy) for an unknown indication. On the same day, 3-hour glucola test (as reported) was performed and no congenital malformation was noted. On 21-Dec-2018, patient underwent Group B streptococcus (GBS) culture test which was negative, and no congenital malformations were noted. 2 months and 19 days after vaccination, the mother delivered a full-term female neonate at 39.4 weeks gestation. Pregnancy complications were reported as meconium and fetal intolerance of labor. The delivery method was reported as forceps. The neonate's birth weight was 3858 grams, head circumference was 34.5 cm and body length was 53.3 cm. The APGAR scores were 7 (one minute) and 9 (five minutes). APGAR score was not reported for 10 minutes. There was no major congenital malformation was noted. The outcome of the events was not reported. The mother's estimated delivery date (EDD) was reported as 15-Jan-2019. This case is linked to 201805302, the corresponding maternal pregnancy report.; Reporter's Comments: A male neonate patient was born with fetal intolerance of labor (fetal distress) and meconium in amniotic fluid, more than 2 months after maternal receipt of AFLURIA QUADRIVALENT vaccine at 28 weeks of gestation (considered as fetal exposure during pregnancy). Considering implausible temporal relationship and biological implausibility, the event fetal distress during labor assessed as not related. The event meconium in amniotic cavity can be alternatively explained by fetal distress rather than suspect vaccine. Hence, causality assessed as not related. The decision to administer a vaccine during pregnancy is related to medical decision made by the mother and her physician and is not related to any property of the medication. Hence, the event fetal exposure during pregnancy assessed as not related considering the intended use of the vaccine. The company assessed the events 'fetal intolerance of labor and meconium in amniotic fluid' as serious (medically significant).
I've already had Covid; I've already had Covid; The facility just called and said she needs another shot because the dose she received was mixed with sterile water due to running out of the "saline"; The facility just called and said she needs another shot because the dose she received was mixed with sterile water due to running out of the "saline"; This is a spontaneous report from a contactable consumer. A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8732), dose 2 via an unspecified route of administration on 27Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient said I have already had covid on an unspecified date. The facility just called and said she needs another shot because the dose she received was mixed with sterile water due to running out of the saline (off label use and product use issue) on 27Mar2021. Caller states the vaccination site claims that someone from Pfizer told them that day that sterile water could be used as a diluent. When asked who at the site told her that she said she doesn't know. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results. The outcome of the events off label use and product use issue recovered and others was unknown.  Follow-up attempts are completed. No further information is expected.
Shingles outbreak; This spontaneous report was received from a currently 78-year-old male patient, via GlaxoSmithKline. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On an unspecified date in 2016 (reported as "6 years ago"), the patient received vaccination with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not provided). Other suspect vaccines included varicella zoster vaccine rge (cho) (SHINGRIX) also administered for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not provided).   The patient reported that on an unspecified date in approximately in 2022, reported as a few weeks ago, he went to a doctor appointment for other problems and when the doctor looked at his back, the doctor informed that he was having a shingles outbreak.   At the time of reporting, the outcome of shingles outbreak was not provided.   The patient did not provide any causality assessment between the vaccination with zoster vaccine live (ZOSTAVAX) and with varicella zoster vaccine rge (cho) (SHINGRIX).
A bump and a 3 inch rash at the site of administration of the vaccine; A bump and a 3 inch rash at the site of administration of the vaccine; This spontaneous case from  was received on 24-Sep-2020 from other non-health professional via The Agency (reference number: SEQW20-02263) and concerned a patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.   On 17-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 283849 and expiry date was 30-Jun-2021.   On the same day, after receiving Flucelvax QIV, the patient developed a bump and a 3-inch rash at the site of administration of the vaccine. The patient did not receive any treatment measures associated with the events.  On an unspecified date in Sep-2020, the patient recovered from the events.  The reporter did not provide a causality assessment to Flucelvax QIV.   The case was assessed as non-serious.  This case is linked to cases 202004678, 202004696, 202004697, 202004698, 202004699, 202004700, 202004701, 202004702, 202004703, 202004705 and 202004706 (due to the same reporter).  Additional non-significant information received on 06-Jan-2021 from other non-health professional via The Agency (reference number: SEQW21-00065) with additional information received on 12-Jan-2021 from other health professional (reference number: SEQW21-00149) (being processed together): Two reporters were added. Reference numbers added. No changes in narrative.  Company comment: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed vaccination site rash and vaccination site mass. The patient's medical history and concomitant medications were not reported. Chronology is plausible. Causality is assessed as possibly related for both events.; Sender's Comments: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed vaccination site rash and vaccination site mass. The patient's medical history and concomitant medications were not reported. Chronology is plausible. Causality is assessed as possibly related for both events.
Patient reported swelling down her arm that she described as "welts". she also complained of headache, nausea, body ache, and fatigue for 48 hours after immunization.
Vaccine was given without gloves to patient in left arm close to joint which resulted in more pain directly after injection. Patient did not have pain with first injection. Patient had side effects to vaccine also which included tachycardia, hypotension, severe shaking chills. Unable to upload picture of injection site.
Report received on 03.Apr.2012 from a healthcare professional and forwarded by Crucell Vaccines. This case concerns a male patient of unspecified age who received the first dose of VIVOTIF (batch number not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. Some time after vaccination, the patient developed a 2x2 red, non-vesicular rash on his leg. The outcome was not reported. The event was considered non-serious. During internal review on 11.Oct.2012 it was noted that the Crucell reference number was CVAE-017-2012.
12/21/2021: Pt admitted post 7 days of COVID symptoms. Reports dry cough followed by fatigue, diaphoresis and chills, and fatigue. Was on 4-5L of supplemental O2 in ED, but responding to breathing treatments and improving slowly. Began Dex  12/22/2021: Pt discharged. Doing well and on room air. Discharged with symbicort and 4 more days of dexamethasone. Discussed self quarantine for 8 more days
Developed swollen and red arm at injection site 1 week later. Also has a knot at the site of injection.
Client came the following day to the clinic and said she was having an "allergic reaction that keeps getting worse from the latex in the pneumonia shot." She checked online and found a website that said people w/latex allergies may have a severe reaction to the shot. Client stated, "It started with my arm getting sore and painful and feeling like it was getting cut off. This morning it went to my throat." She stated she was taking Benadryl and other medication that doctors have told her to take in the past. Two public health nurses strongly recommended that she see her doctor or go to an ED. She said she had to go to class.
After the second shot, I had the expected flu like symptoms 14 hours the administrated dose. Symptoms lasted about 8 hours and included fever, excessive sweating, vertigo, and paranoia. After the 8 hour adjustment period, I returned to full health. Within a few days, I began to excessively sweat at night, regardless of room temperature. This was occurring about 4x a week. After my third dose, I've been excessively sweating nightly.
Tested positive for COVID 19 on 16Dec2021; Tested positive for COVID 19 on 16Dec2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 14-year-old female patient received BNT162b2 (COMIRNATY), on 13May2021 as dose 1, single (Batch/Lot number: unknown) and on 03Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Dec2021, outcome "unknown" and all described as "Tested positive for COVID 19 on 16Dec2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Dec2021) Positive. Reporter's 14-year-old daughter received booster dose of Comirnaty and experienced adverse events the following day-severe headache, sore throat, fatigue Optional Information included that patient received 1st dose of Comirnaty on 13May2021 did not experience any adverse events, 2nd dose of Comirnaty on 03Jun2021- no adverse events. Tested positive for COVID 19 on 16Dec2021. Received Comirnaty booster on 03Apr2022 and experienced adverse events the following day. Event took place after use of product.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.