chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  10/13 COVID vaccine dose #5 and Influenza, quadrivalent dose 10/25 Pt contacts team to report "an itch is going below the skin. He said he received the booster shot and the flu shot. And don't know if that has anything to do with it." 10/26 Pt reports he remains with itchiness mainly to his left arm and back. No rash per patient. He has tried taking OTC Benadryl with no relief." 10/28 Pt reports "my Left arm where they put started itching and now from the neck down to my waist and towards the back." Denies rash, no skin redness, no swelling on affected areas. "There's nothing to see but I feel the itching inside!" Took diphenhydramine every 4 hours, applied Calamine lotion with no effect. 11/01 PCP contacts pt who reports "since the day after vaccinations he started with itching down his left arm then the itching has progressed to his entire back and at present itching has moved to his right arm. He reports in the interim he has used benadryl cream, benadryl oral medications, calamine lotion and OTC cortisone cream all with minimal improvement. Patient describes the itch as "under the skin, not painful, it's more of an annoyance". At present, patient reports he is not having difficulty breathing, denies any pain/swelling at injection site. Patient reports he did not experience any feelings of faintness, swelling of tongue, wheezing/cough, feelings of impending doom." Prescribed prednisone dose pack.
After experiencing relatively minor soreness and aching at injection site for the first 2 months, extreme shoulder pain started somewhat sporadically and in various ways, ranging from intense achiness to shooting pain
Was in bed all weekend.; weakness; Pain on right side of leg; Loss of appetite; Fever; Chills; Headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HYPOKINESIA (Was in bed all weekend.), ASTHENIA (weakness), PAIN IN EXTREMITY (Pain on right side of leg), DECREASED APPETITE (Loss of appetite) and PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 HYPOKINESIA (Was in bed all weekend.), ASTHENIA (weakness), PAIN IN EXTREMITY (Pain on right side of leg), DECREASED APPETITE (Loss of appetite), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, HYPOKINESIA (Was in bed all weekend.), ASTHENIA (weakness), PAIN IN EXTREMITY (Pain on right side of leg), DECREASED APPETITE (Loss of appetite), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.     Reporter did not allow further contact
took three Moderna Vaccines and then got the Pfizer Covid-19 Vaccine in the end.; his mother got a little bit sick from it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program.  An 85-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (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: Moderna (Dose: 01), for COVID-19 Immunization; Moderna (Dose: 02), for COVID-19 Immunization; Moderna (Dose: 03), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "took three Moderna Vaccines and then got the Pfizer Covid-19 Vaccine in the end."; ILLNESS (non-serious), outcome "unknown", described as "his mother got a little bit sick from it".  Additional information: The reporter stated that his mother took three Moderna Vaccines and then got the Pfizer Covid-19 Vaccine in the end. He stated as well that his mother got a little bit sick from it and he wanted to know if it is normal to have Moderna all three shots and then have a Pfizer Vaccine at the end.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a one dose of VARIVAX (Merck) (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient experienced mouth sores. It could not have been determined if the mouth sores developed before or after the vaccination. The outcome of the adverse event was not provided. The relatedness between mouth sores and VARIVAX (Merck) was not reported. Additional information has been requested.
I decided not to have the second shot as my reaction was so severe.; 3 weeks of / rash / my reaction was so severe; 3 weeks of swelling / my reaction was so severe; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced rash, swelling and incomplete course of vaccination. On an unknown date, the outcome of the rash and swelling were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the rash and swelling to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination not reported. The patient took the first shot and had never had such a reaction to a shot prior to this. 3 weeks of swelling and rash. After discussion with a doctor the patient decided not to have the second shot as her reaction was so severe.
Approximately 10 minutes post injection, subject began to feel throat tighten. After taking a drink of water, the subject felt the throat tightness becoming worse. The patient could talk but her voice wounded horse. Heart rate increased. After consulting with physician at vaccine administration site, patient was transferred to the emergency room for treatment. Blood pressure was 200/100 in the emergency room. Patient was treated with benadryl, steroids and pepcid. Patient recovered
Swelling at injection site, became red, hard and very hot to the touch.  Fever and chills.  Spot started out the size of fifty cent piece and grew to cover upper arm growing more and more painful  Returned to dr on 11/21/2014 he prescribed antibiotics. Cephalexin 500mg 2 tabs 2x daily.
Fine rash on face, back of neck, both hands, inside both arms, swelling of face entirely, eyes, lips, even arms. My body felt swollen. This lasted for two weeks. I administered BENADRYL & felt better.
tingling sensation on her finger and toes; numbness on hands and feet; tremor and shaking on her legs; This spontaneous report was received from a Pharmacist and refers to a 12-year-old female, who was the pharmacist's daughter. The patient's concurrent conditions and medical history were not reported.   On 11-AUG-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1775811, expiration date: 07-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided); and  meningococcal vaccine a/c/y/w conj (crm197) (MENVEO), (strength, formulation, lot #, expiry date, route of administration, and indication were not provided).  On 15-OCT-2022, the patient received a dose of influenza vaccine inact split 3v (FLULAVAL), 12 hours later, the patient developed tingling sensation on her finger and toes (Paraesthesia of fingers), numbness on hands and feet (Numbness of extremities), tremor and shaking on her legs (Tremor). Her body was also shaking. The patient went to an Emergency Room, saw a physician and received unspecified lab tests and all were normal. The patient was discharged and was not admitted. She did recover for most symptoms except some numbness on her left leg but it goes away after she stands up.   The causal relationship between numbness on paresthesia of fingers, numbness of extremities, tremor  and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
A nurse reported that a 15 month old female received injections of a 1st dose of Prevnar and a dose of Infanrix on 1/12/01. The pt had a "low-grade" fever of 99F (R), prior to receiving the vaccinations. Three to four hours, post vax, the pt experienced a fever, decreased appetite, drowsiness and nasal congestion. It was noted that the nasal congestion was persisting 1 week later. Follow up information was received on 03/06/2001 that clarified the sites of vaccination injections; right thigh for Prevnar and left thigh for Infanrix. Also, the patient had received 3 previous doses of Infanrix prior to this current one. The patient received no other vaccinations within four weeks of 01/12/2001, and was receiving no other medications concomitantly. The patient's symptoms lasted until the end of January 2001.
This spontaneous report as received from a consumer refers to a 6 months old female patient. The patient was vaccinated with dose 1 of ACTHIB (lot #, dose and route not reported) at 2 months of age (approximately in July 2012). She then switched providers and was vaccinated a first dose of LIQUID PEDVAXHIB (lot #, dose and route not reported) at 4 months (approximately in September 2012) and was vaccinated with a second dose of LIQUID PEDVAXHIB (lot #, dose and route not reported) at 6 months on 14-NOV-2012. The patient's mother was reporting that she was concerned about the dosing regimen and was worried her daughter had been given too much of the vaccine. She did not mention an AE. Additional information is not expected.
A-Fib recurred with a vengeance; A-Fib recurred with a vengeance; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9262), via an unspecified route of administration on 10Feb2021 13:00 at single dose (arm left) for Covid-19 immunization. Medical history included atrial fibrillation (AFib) treated well with Diltiazem. The patient had no allergies to medications, food and other products. Concomitant medication included diltiazem for Afib. On 11Feb2021 11:00, 22 hours after vaccine, A-Fib recurred with a vengeance, requiring an emergency room (ER) visit and overnight stay in hospital in order to stabilize. The patient was hospitalized on 11Feb2021 to 12Feb2021. The patient was treated with diltiazem I.V. for 12 hours. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient received diltiazem within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient been tested for COVID-19. Outcome of event was recovered on an unspecified date.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 27-MAY-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210605676.
Noticed numbness and stabbing pain at injection site and around the site. Over the next 24-36 hours, there was pain when anything came in contact with the arm. On 11/14/03, after being grabbed by co-worker in such a manner that his arm came in contact with co-worker's chest, the deltoid region proximal to shoulder from approximate injection site with numbness. No loss of sensation below injection site or fingers.
3 hours later, severe pain upper left arm. During night onset of severe body aches, throbbing headache, sleeping most of next day. Symptoms continued for 48 hours, easing later in day two.
This case was reported by a physician via call center representative and described the occurrence of rigors in a 62-year-old male patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020. Previously administered products included SHINGRIX with an associated reaction of chills (For tolerance to the 1st dose received on 9th February 2018, refer case US2018GSK069429). Concomitant products included Venlafaxine, Aspirin, WELLBURTIN XL, Atorvastatin, BRILINTA, Metoprolol Succin and (NOS) Omega Fatty Acid. On 10th April 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In April 2018, less than a month after receiving SHINGRIX, the patient experienced rigors. The patient was treated with TYLENOL and (NOS) BENADRYL. Rechallenge with SHINGRIX was positive. In April 2018, the outcome of the rigors was recovered/resolved. The reporter considered the rigors to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The patient experienced severe rigors with 2nd dose of SHINGRIX. The reaction lasted for about 12 hours approximately. Before the second dose was administered patient was pre medicated with TYLENOL and BENADRYL.
Patient waited 15 min post vaccination with no issues. While driving home she felt her heart pounding, dizziness and her tongue began to swell. She drove back to the vaccination center for medical attention. Patient did not have difficulty speaking or any signs of cyanosis. Denied shortness of breath. Patient stated she only had yogurt and coffee this morning, but no water. After 15 minutes of relaxation, BP decreased to 150/90. Patient stated she felt much better. Patient moved to post vaccination for additional 15 min monitoring.
chills, nausea, headache, some site pain, some muscle pain, fever, tiredness
Initial case received from a health care professional on 24 November 2010. It involves a pregnancy case, and is also a case of inappropriate schedule of vaccine administration. A 16-year-old pregnant female received an intramuscular injection of FLUZONE (lot number UH180AA) on 15 October 2010. She was later inadvertently given an intramuscular dose of FLUZONE (lot number U3775CA) on 12 November 2010. The patient did not experience any adverse reactions following either vaccination. Information regarding the patient's medical history and current pregnancy were not reported. Follow-up information was received 28 January 2011 from a health care professional. On 26 November 2010, fourteen days after receiving FLUZONE (lot number U3775CA) on 12 November 2010 and 42 days after she had received FLUZONE (lot number UH180A) on 15 October 2010, the patient developed a rash. The patient's last menstrual period occurred on 04 June 2010 and her estimated date of delivery was 12 March 2011. Gestational age calculated at 19 weeks at the time of vaccination on 15 October 2010. Current pregnancy history was negative for alcohol, tobacco, drugs and HIV. Prenatal testing was negative for MSAFP (maternal serum alpha-fetoprotein). Outcome for rash was not reported. Follow-up information was received from the health care professional on 17 February 2011. The patient was treated with BENADRYL 25-50 mg PO at bedtime. The rash recovered on an unspecified date; per the reporter, the patient was seen in the office on 08 December 2010 and the rash was not visible at that time. Follow-up information received on 25 April 2011 from a health care professional. Per the reporter, no additional information is available at this time. No information regarding the patient's pregnancy outcome was provided. Follow-up information received on 22 June 2011 from a health care professional. The patient's last menstrual period was on 04 June 2010. She had no previous pregnancies, no elective or spontaneous abortions, and no fetal deaths. She kept all prenatal appointments. Neural tube defect screening, Down Syndrome screening, Trisomy 18 testing negative for 19.0 weeks. Anatomy screen was within normal range. The patient had no pregnancy complications. Both the patient and the infant's father were reported to be healthy. On 18 February 2011, the patient delivered a single male infant via normal vaginal delivery at 40 weeks gestation. There were no complications of delivery. Apgar scores were 8 and 9 and one minutes and eight minutes respectively. The infant weighed 7 lbs (3.18 kg.) at birth. There were no congenital anomalies. Documents held by sender: None.
Severe migraine that lasted 8 hours. Headache continues 4 days after vaccination.  Dizzy, fever, body aches. 4 days after still having hot flashes and headache.
Tired; Tenderness; Redness; Fatigue; Pain at injection (left); Rash; Bruise; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONTUSION (Bruise), TENDERNESS (Tenderness), RASH (Rash), ERYTHEMA (Redness) and FATIGUE (Fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced CONTUSION (Bruise), RASH (Rash), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at injection (left)). On 28-Jan-2021, the patient experienced TENDERNESS (Tenderness) and ERYTHEMA (Redness). On 30-Jan-2021, the patient experienced FATIGUE (Tired). On 23-Jan-2021, CONTUSION (Bruise), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at injection (left)) had resolved. On 27-Jan-2021, RASH (Rash) had resolved. On 01-Feb-2021, TENDERNESS (Tenderness) and ERYTHEMA (Redness) had resolved. At the time of the report, FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included neosporin ointment, lidocaine and recommended getting vaccine in different arm.
Starting itching post injection. Swelling started that night. Headache, returned to clinic. Site: left arm posterior raised 12cm x 11cm, pruritic, red, warm to touch. Seen by physician at clinic 6/21. Acetaminophen 500mg tab every six hours prescribed.
Patient complaining that there is a bump (small knot) at the site of injection, bump can be felt, it is not hot, and patient states no other problems.
Injection site reaction; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site reaction in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site reaction (Verbatim: Injection site reaction). The outcome of the injection site reaction was not reported.   It was unknown if the reporter considered the injection site reaction to be related to Arexvy.  It was unknown if the company considered the injection site reaction to be related to Arexvy.   Additional Information: GSK Receipt Date: 19-OCT-2023 The patient took Arexvy shot and experienced injection site reaction.  The reporter said that they watched it for a couple of days. The reporter did not agree to follow up from GlaxoSmithKline.
A couple of hours after the vaccine I started experiencing headaches that gradually started getting worse. At night I also had fever, chills, sore throat, body aches, flu like symptoms. In the middle of the night I woke up with heart palpitations. Those symptoms lasted for about 5 days. Monday I still had a slight sore throat, and I started with my throat feeling scratchy and then a sudden cough. I still have those (sore throat and cough), My BP has also been compromised since the 1st dose and still is not back to normal. It shoots up all of a sudden.
Large 3"×3" bruise appeared around the injection site with muscle pain and aching and 12 days later there's not much change in the bruising and pain
Intermittent bilateral leg pitting edema from knees down. Throbbing and tingling on bilateral soles of feet.
After getting the first shot and the patient test positive for Corona virus; After getting the first shot and the patient test positive/perhaps positive; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable pharmacist reported that a patient of unspecified age and gender started to receive BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, first dose on an unspecified date at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. A pharmacist in a hospital wanted to know if after getting the first shot and the patient test positive for Corona virus, how long do they have to wait to get the second? A colleague is perhaps positive. He doesn't know if they got tested. Outcome of the events was unknown.   Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between reported event and BNT162B2 cannot be excluded.
This event is a vaccination administration error due to patient's age as opposed to what the suggested appropriate age range is.
PATIENT REPORTED THAT SHE FAINTED AT HOME 2 DAYS AFTER VACCINATION. SHE WAS RUNNING A FEVER, BUT FELT BETTER 3 DAYS AFTER VACCINATION. SHE DID NOT GO TO THE DR.  PATIENT REPORTED THIS TODAY
This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, and concurrent conditions was not reported. Concomitant therapies included sterile diluent. On 06-DEC-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N001528  expiration date 13-JAN-2018, (strength, dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature ranges between 6°F to 14°F (9.3°F) during a time frame of 13 hours. Previous temperature excursions included 6°F to 14°F (8.1°F) during a time frame of 12 hours which were called by a data logger.