chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is in follow-up to report (s) previously submitted on 6/14/2007. Initial and followup Information has been received from a physician concerning a 4 month old patient who on 08-MAY-2007 was vaccinated with Rotateq second dose (LOT #656189/1239F). Concomitant therapy included PEDVAXHIB (MSD LOT # 6553961437F), PEDIARIX (Lot # AC218096CA) and PREVNAR (lot # B08690C). On 08-MAY-2007 about 20 minutes after receiving the vaccine the patient developed vomiting (also reported at 10 minutes after vaccine administration). Subsequently, the patient recovered from vomiting on 08-MAY-2007.  It was reported that the patient sought unspecified medical attention. Additional information is not expected.
Case PHEH2016US026066, is an initial spontaneous report received from a pharmacist on 05 Oct 2016. This report refers to a 80 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 168804) at an unknown dose intramuscularly on 05 Oct 20016. The pharmacist stated that, partial dose of FLUVIRIN PFS syringe was given to patient. The barrel on the PFS locked up and the pharmacist could not deliver the entire dose of FLUVIRIN. No adverse event was reported following this administration error (underdose).
I had a stuffy nose. Rash at the injection site. Headache. Ear ringing. Ear pressure. Body aches. Extreme fatigue. Developed two small circular areas (2-4mm)  3 days post vaccination on my right forearm and left upper arm with a reddened circle with a white center, mild itching also noted. These areas disappeared when cleaned and antibacterial ointment applied overnight.
Approximately 7 hours after influenza vaccine, developed the following symptoms in the specified order: symptoms developed acutely within 1-1.5 hours. Whole body chills/goose bumps; whole body myalgias; severe headache; severe sleepiness. Temperature taken (after drinking hot tea and having taken a hot bath) was 101.2 degrees F, 15 minutes later, temp was 100.4 degrees F. Slept 12 hours straight, awoke - temp 96.5 degrees F; chills and myalgias gone - mild residual headache and sleepiness. All symptoms gone after 48 hours. This the 1st time ever experiencing these symptoms after a flu shot.
pt recvd vax & w/in 48 hrs & devel facial swelling, rash, tight throat, h/a & dizziness which lasted 2 wks;
2nd Dose: - Pain in the injection arm roughly ~9 hours after. - Pain escalated from a 1-2 to a 4-5 throughout the night. - Pain on left arm, near first injection site returned. Unsure if correlation or just early signs of body fatigue/soreness starting. - Minor swelling on right arm & was warm to touch. Applied ice pack and went to sleep. - Pain escalated to a 5-6 the following morning (6/16) at ~8-10am. - Full body fatigue started around 10-11am on 6/16. (No mental fog present, fatigue incl. soreness & general pain) - Throughout the day, chills are present intermittently. - Throughout the day, nausea is present intermittently. - At time of writing (9:05pm 6/16) pain is at a 3-4 on right arm, pain throughout body is a 2-3 depending on location. OTC pain medication such as Tylenol has limited effect.  1st Dose: (not sure if you want this but I will add it anyway) Received 5/13/2021 @ 1:40pm @ Clinic (same location as above; lot # above as well) - Pain in the injection arm roughly ~3-4 hours after. - Pain remained a low level 2-3 on a general pain index throughout the day. - Following morning, at ~8am (5/14) pain was a 3-4. Responded to OTC Tylenol immediately. - Arm was tender for 3-4 days, until it resolved.
have been dealing with nerve pain; This case was reported by a consumer and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingle vaccine three years ago and now patient had been dealing with nerve pain ever since.  The patient never had this pain before.
Left side of face went numb within a minute after getting the shot, subsided, but continues to feel numb, tingly, not visiably saggy but can't hold smile without forcing it and cheek, mouth quiver-feels like weak muscle in that area.  Eye feel slightly heavy but can open and close.
Postive Covid Test/treated with Paxlovid on 3 day after test/Negative test on 5/25/22. Symptoms-cough, fatigue, congestion, off taste in mouth
On night vaccine given felt feverish in her face.  Arm very sore.  Next night the pain would wake her up when she would roll on the arm.  Slightly swollen at sight.  05/22/2003:  Checked on patient and doing better today.  Arm not very sore and swelling gone.
2wk p/vax joint pain, fingers & lt ankle swelling-dragged ankle when walking, T99.8-101.2 swollen cervical lymph nodes;hair loss size of quarter on top of head;fatigue & joint pain still persists;
Swollen lymph nodes; Fever; Body aches; Nausea; Vomiting; Headache; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 05May2021 at 14:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's disease, rheumatoid arthritis, postural orthostatic tachycardia syndrome (POTS) and allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 at 14:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 06May2021, the patient experienced swollen lymph nodes, fever, body aches, nausea and vomiting, headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen lymph nodes, fever, body aches, nausea and vomiting, headache were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Approximately 20 minutes after receiving 2nd dose of Pfizer Covid-19 vaccination, pt reports dull feeling in left-side of chest. Pt reports no difficulties breathing, rash, itching, fever, or other issues. Pt escorted to EMS who took vital signs. BP 120/85, HR 65, O2 100% on RA, Temp 98.7F. Pt provided with juice box. After approximately 20 more minutes of waiting, pt reports symptoms have not improved, but are also not worse. No other issues noted. Pt ambulated by self out of clinic home. Pt refused to have vitals rechecked.
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Additional Details: dizziness and chilled feeling at home later in the evening many hours after vaccination. patient fell and hit head and tailbone but reported no major injuries.
Local reaction at site of injection - erythema & swelling no vesicles or pustules.
About 8 days after the injection administration, I started getting a rash on the injection site. It was about 3 inches in diameter, itchy, and warm to the touch. I still have it today, but it is fading and not as itchy or as warm. Prior to this, the only other symptoms were slight tenderness/pain at the injection site.
Patient experienced redness that spread down towards the elbow, itching at injection site, muscle pain in legs.
I started to get a headache then became more fatigued throughout the evening. I went to bed around 9 pm and had some chills and mild body aches so I took some Tylenol. I woke up around 12pm with sore muscles and cramps/aches in my back, hips, legs, and neck. I also had a mild fever of 100.7 and was nauseous. I took some Zofran for nausea. I had chills and was flushed and sweating. That next day I felt like I had been hit by a truck, I was very fatigued, had little to no appetite, and had a pounding headache. I slept the entire day 1/25. The following day 1/26 I felt better but still groggy, I slept the majority of the day before heading off to work.
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-MAR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021826, expiration date: 25-JUN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Developed skin condition on throat & upper chest: felt dry like sunburn with "itching" that felt like razor blades cutting into skin & would awaken me at night. Within a few days started getting itchy areas that developed into scaly patches. Some still are appearing on arms & front of legs. Dr. prescribed Triamcinolone Cream for 2 wks, which gave almost immediate relief. My immune system went into "overdrive". My internal medicine doctor told me to NOT get the second shot. My husband received the Shingrix shot at the same time & date I did with no adverse effects except a sore arm for a day.
PERIOD RESTART AFTER MENOPAUSE FOR 18 MONTHS; SWOLLEN LEGS WITHIN 24 HOURS OF RECEIVING VACCINE; DEEP CHILL IN ARM SPREADING INTO CHEST; This spontaneous report received from a patient via a company representative concerned a 56 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the patient experienced deep chill in arm spreading into chest. On 13-MAR-2021, the patient experienced swollen legs within 24 hours of receiving vaccine. On an unspecified date, the patient experienced period restart after menopause for 18 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the period restart after menopause for 18 months, deep chill in arm spreading into chest and swollen legs within 24 hours of receiving vaccine was not reported. This report was non-serious.
Patient parent called office approx. 2p. c/o baby hot (no-temp taken) given TYLENOL. Screaming nonstop uncontrollable left thigh extremely swollen and red with redness up to mid abdomen. Epinephrine given in office & sent home on steroids. Sxs resolved within 30 mins.
Nurse advised 19 month old patient was given QUADRACEL 19 today in error, wants to know how to proceed with no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Medical Information (Reference number- 00428638) and transmitted to Sanofi on 13-Jan-2021 via call-center.  This case involves a 19-Month-old female patient who nurse was given diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [quadracel] (lot number: C5755AB and expiry date was unknown) via an unknown route at unknown administration site for prophylactic vaccination in error and wants to know how to proceed (product administered to patient of inappropriate age).   The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   It was an actual medication error case due to product administered to patient of inappropriate age (latency: unknown).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I first noticed swelling under my left armpit and its the size of a baseball. I have some pain when I sleep and when I raise my arm up.
severe chills for 9 hours Headach for 36 hours Muscle aches for 12 hours Fatigue for 72 hours Appetite loss for 36 hours Nausea for 12 hours
Patient with persistent pain to left deltoid area, plus tender to palpation and pain radiates down the arm. No previous pain or injury to arm.
Patient was administered a Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Company was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated on 03/19/21 and has since received dose 2 on 04/09/21
Tested positive for covid 19 after receiving a booster dose of the Moderna Covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for covid 19 after receiving a booster dose of the Moderna Covid 19) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 012N20A and 012L20A) for COVID-19 vaccination.     Patient did not have any allergies.  Concurrent medical conditions included Blood pressure high. Concomitant products included LEVOTHYROXINE and ATORVASTATIN for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for covid 19 after receiving a booster dose of the Moderna Covid 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for covid 19 after receiving a booster dose of the Moderna Covid 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2022, SARS-CoV-2 test: (Positive) Positive.         Patient was taking unspecified high blood pressure pill medication.
bruising on her left arm in 2 places and more "blurish-blue bruising" on right arm; some tenderness; soreness around injection side; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising on her left arm in 2 places and more "blurish-blue bruising" on right arm), TENDERNESS (some tenderness) and VACCINATION SITE PAIN (soreness around injection side) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 024C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form(s). On 13-Jun-2021, the patient experienced CONTUSION (bruising on her left arm in 2 places and more "blurish-blue bruising" on right arm), TENDERNESS (some tenderness) and VACCINATION SITE PAIN (soreness around injection side). At the time of the report, CONTUSION (bruising on her left arm in 2 places and more "blurish-blue bruising" on right arm), TENDERNESS (some tenderness) and VACCINATION SITE PAIN (soreness around injection side) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
TIRED; MUSCLE SORENESS; This spontaneous report received from a consumer concerned a 72 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, and muscle soreness on 11-APR-2021. This report was non-serious.
This report describes the occurrence of mercury poisoning in a male child of unspecified age who was vaccinated with Hep B vaccine recombinant (Engerix B) for prophylaxis. This report was received as part of a litigation proceeding and has not been verified by a physician or other healthcare professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject received injections of Engerix B on 19 Dec 1997 (lot ENG2424A2), 16 Feb 1998 (lot ENG2357A2), and 20 APril 1998(lot ENG2427A2), the third injection was administered four months after the first injection, rather than the recommended interval of six months. He also received diptheria and tetanus toxoids and acellular pertussis vaccine (Acel Immune 16 Feb 1998, 20 April 1998, and 19 Nov 2000, and Tripedia 22 Feb 1998, and 22 June 1998. Haemophilus influenza type B conjugate vaccine (Hib Titer 16 Feb 1998, 20 April 1998, 22 June 1998, and 08 April 1999) inactivated poliomyelitis virus vaccine (IPOL 16 Feb 1998, 20 June 1998) MMR II 08 April 1999), and varicella virus vaccine (Varivax 05 Jan 1999) The subjects attorney alleged that, as a result of the vaccines administered, the subject suffers from the effects of mercury poisoning. The mercury in this report is considered medically serious.
Vaccine administered more than 6 hours after reconstitution (given 15h 58 min minutes after).  The vaccine was drawn up immediately before administration.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 11-FEB-2013 the patient was received an expired dose of VARIVAX (merk) (lot number reported as 1706Z, expired date 09-DEC-2012) (dose, route and injection site were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. The action taken and outcome were not provided. It was unspecified if the patient sought medical attention. Additional information has been requested.
Patient was wheezing, lips swollen, teary eyes, and sweating. She stated that her throat was swollen and that  she was having trouble breathing.   She was alert and well oriented but her voice was muffled. With consent, she was administered an epi pen  on he left thigh. Within a few  minutes, she said that the swelling was going down and she was taken care of the 911 services before vitals were taken and they took over.
Nausea and vomiting within 45 minutes of vaccine.  Left side facial numbness, allergic swelling of face within 1 hour of vaccine, lasting 24 hours with Benadryl & Pepcid given as treatment. Numbness of face occurring 1 week post vaccine. Benadryl given as treatment.
A spontaneous report was received from a consumer concerning a 46-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events heart beating and had abnormal palpitations in weird patterns, could feel her heart beating in chest /palpitations; no other side effect except that her heart rate was elevated more so than normal/heart rate increased.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the events heart beating, had abnormal palpitations in weird patterns and she could feel her heart beating in her chest. On the same day the patient experienced her heart rate was elevated more so than normal.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 8 Feb 2021 the outcome of events heart beating and had abnormal palpitations in weird pattern, could feel her heart beating in her chest, that her heart rate was elevated more so than normal was resolved.
shingles by her eye; real sick; real sick, severe flu-like symptoms; hurt so bad; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles by her eye) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), LISINOPRIL, CETIRIZINE and NAPROXEN for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.   On 13-Apr-2021, the patient experienced MALAISE (real sick), INFLUENZA LIKE ILLNESS (real sick, severe flu-like symptoms) and PAIN (hurt so bad). On 17-Apr-2021, the patient experienced HERPES ZOSTER (shingles by her eye) (seriousness criterion medically significant). At the time of the report, HERPES ZOSTER (shingles by her eye), MALAISE (real sick), INFLUENZA LIKE ILLNESS (real sick, severe flu-like symptoms) and PAIN (hurt so bad) outcome was unknown. Not Provided  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Treatment included valaciclovir hydrochloride, 1 GM 1 tab three times a day, erythromycin ointment in right eye three times daily and methylprednisolone Dose Pak.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded. Some vaccines have been known to exacerbate latent herpes zoster.