chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a adult female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 21 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. The reporter considered the shingles to be unrelated to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient developed Shingles 3 weeks later diagnosed by MD. The reporting HCP did not believe it to be related to the Shingrix.
Pt had a reaction from her shot. Mom stated that post she dropped pt off at Daycare. The Daycare worker call her back because c/o head hurting turned blue around lips then pt went limp. It fell out of chair daycare worker caught her lowered her to the floor pt did not fully loose consciousness but she would not respond verbally or to stimuli. By the time mom got back to daycare she came back started speaking the episode lasted for 20 minutes mom immediately took her to doctor. He could not explain to mom what happen to patient. It could be possibly a reaction from the vax or something else. Mom wanted me to be aware of the episode because the literature I gave her said that a rare reaction like this one could occur.
Time of injection 2:30, painful.  Approx. 3:30 pm left arm injection site began throbbing, then unable to move arm comfortably.  Followed by onset of malaise, fatigue, localized pain, redness, swelling.  Moved into total body muscle/joint pain.  Inability to weight bear - Thursday 2.05.15.  Fatigue, flu-like symptoms, no appetite.  Injection site increase redness/swelling/pain. Headache.  Temp 100.5 (typical baseline 97.1). No appetite.  Total body ache.  Treated with local ice to hips.  NSAIDs.  Oxycodone 5 mg (Rx for chronic pain fibromyalgia), fluids.  None to minimal relief.  Acupuncture treatment to local injection site 02/06/16; suggested reporting.  Phoned PCP office, spoke with tech/nurse described symptoms/tx.  Told me I'd done everything they would have suggested.  If persist swelling/redness seek medical attention urgent care with concern for cellulitis locally; local site resolving at time of this report.  Other symptoms continue with less intensity but extreme fatigue, head congestion, inability to do normal daily living activities due to lethargy/fatigue/pain.
Information was received from a lawyer regarding a case in litigation concerning a female plaintiff of unspecified age. It was claimed this plaintiff suffered personal injuries and damages as a direct and proximate result of being inoculated with ZOSTAVAX. The plaintiff was inoculated with ZOSTAVAX on or about 10-AUG-2012 (dosage, route, lot # and site of administration unspecified) as recommended for routine adult health maintenance for the prevention of shingles.  It was claimed that the vaccine did not prevent shingles as intended, but rather caused the plaintiff to contract a persistent strain of herpes zoster. On or about 17-AUG-2012 the plaintiff was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The plaintiff was prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
fever after these two; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever after these two) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever after these two). At the time of the report, PYREXIA (fever after these two) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided. Patient had never tested positive   This case was linked to MOD-2022-506343, MOD-2022-506338 (Patient Link).
The patient was vomiting and "wasn't herself" within a half hour of vaccination and emergency services were called to the store
Vaccines had an expiration date of 03/27/2022. This specific lot number had been taken out of the freezer April 1st. No cases of adverse reactions have been reported.
40 y/o female who refers dizziness 10 minutes after vaccination covid-19. also sensation of heaviness on back of neck.
Soreness; Facial flushing; She could not get her rings off on her left hand; Rash that has spread; Arm irritation to the touch; Itching; Hotness at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hotness at the injection site), PRURITUS (Itching), SKIN IRRITATION (Arm irritation to the touch), PAIN (Soreness) and FLUSHING (Facial flushing) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J209) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hotness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 28-Jan-2021, the patient experienced PRURITUS (Itching). On 29-Jan-2021, the patient experienced SKIN IRRITATION (Arm irritation to the touch) and RASH (Rash that has spread). On 30-Jan-2021, the patient experienced PAIN (Soreness), FLUSHING (Facial flushing) and PERIPHERAL SWELLING (She could not get her rings off on her left hand). At the time of the report, VACCINATION SITE WARMTH (Hotness at the injection site), PRURITUS (Itching), SKIN IRRITATION (Arm irritation to the touch), PAIN (Soreness), FLUSHING (Facial flushing), PERIPHERAL SWELLING (She could not get her rings off on her left hand) and RASH (Rash that has spread) had not resolved and VACCINATION SITE ERYTHEMA (Redness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
I woke up at 7 AM the next day with a very swollen throat - uvula swelling. It felt funny to swallow. I tried to cough it out and spit up blood. I had a phone appointment with an online doctor. The doctor said to go to urgent care. The urgent care doctor gave me prednisone and a script for an epipen. The doctor also sent a referral to an allergy specialist to determine what actually cause the reaction and to tell me whether I should get the second dose or not.
This spontaneous report was received from a licensed practical nurse referring to a multiple unspecified patients of unknown age and genders. The patient's pertinent medical history or concurrent conditions were not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB Intramuscular Injection (lot# M001578, expiration date 21-NOV-2018), (route, dose and anatomical location were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse reactions were reported. It was reported that the therapy was not discontinued. There was no product quality complaint (PQC) involved. This was one of several reports received from the same reporter. Additional information has been requested.
RL - Bright red area 2x2cm. warm to touch, firm and tender. LL - Pale pink area 6x8cm not warm not tender.
Patient came to pharmacy today 11/5/18, stating that they had a reaction after getting the flu shot. Patient said arm was fine until a couple days after getting the shot, then an "achy" feeling started and moved up the arm to the shoulder. Pain is not constant; it comes and goes. Patient could not report any specific thing that seems to irritate it.  Patient reports no swelling, and specified, that the feeling is not necessarily pain, but more "achy."  Patient reports no issues with movement or range of motion, but wanted to let us know and ask what they should do because it is not going away. We are contacting the physician to let them know, and told patient to see physician if pain continues. We will contact patient again in the next day or two to follow up and see if they are still sore.
Patient broke out on forehead, face and neck. Benadryl 12.5mg/ml given (PO).
Patient arrived at vaccine clinic to receive Moderna booster COVID vaccine. She arrived at vaccine station with Pfizer laminated vaccine paper into administration area providing Pfizer vaccines only. RN scanned Pfizer bar code but did not see warning pop up until after dose had already been administered. Patient received a booster of Pfizer COVID vaccine instead of Moderna. Patient and spouse (who accompanied her) were notified of error with administering RN and charge RN. Error was explained, need for any additional follow up were explained, and patient was given contact number for medical center employee health RN in the event they had further questions or concerns.
Severe eczema in underarms and groin area  that lasted six weeks Menstrual cycle ceased for 13 weeks
Hives, sweating, high fever, swelling, redness, pain, nausea, extreme fatigue, cramping, diarrhea, headache
Sore left arm after the injection; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore left arm after the injection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20N, 031H21A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore left arm after the injection). At the time of the report, PAIN IN EXTREMITY (Sore left arm after the injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.   Patient reports no adverse reaction after booster dose.  Treatment information was not provided.   This case was linked to MOD-2021-409816 (Patient Link).
Received two doses of primary pfizer patient got to another clinic and got Moderna; Received two doses of primary pfizer patient got to another clinic and got Moderna; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received two doses of primary pfizer patient got to another clinic and got Moderna), COVID-19 IMMUNISATION (Received two doses of primary pfizer patient got to another clinic and got Moderna) and NO ADVERSE EVENT (No adverse event) in a 3-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer-BioNTech COVID-19 vaccine (The patient received two doses of the primary Pfizer, one in June and one in July.), Pfizer-BioNTech COVID-19 vaccine (The patient received two doses of the primary Pfizer and one in June and one in July). Past adverse reactions to the above products included No adverse event with Pfizer-BioNTech COVID-19 vaccine and Pfizer-BioNTech COVID-19 vaccine.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received two doses of primary pfizer patient got to another clinic and got Moderna), COVID-19 IMMUNISATION (Received two doses of primary pfizer patient got to another clinic and got Moderna) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received two doses of primary pfizer patient got to another clinic and got Moderna), COVID-19 IMMUNISATION (Received two doses of primary pfizer patient got to another clinic and got Moderna) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (Received two doses of primary pfizer patient got to another clinic and got Moderna) and COVID-19 IMMUNISATION (Received two doses of primary pfizer patient got to another clinic and got Moderna).    Concomitant product use was not provided by the reporter. Treatment information was not provided.
Pt developed a red, macular rash on both upper extremities and back on day 5 of Smallpox vaccination. No treatment was necessary.
swelling in the injection site similar to an infiltration; swelling in the injection site / Swollen injection area; Warm to touch; swell up arms; This case was reported by a consumer via call center representative and described the occurrence of injection site infiltration in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site infiltration, injection site swelling, skin warm and swelling arm. The patient was treated with antibiotics nos, doxycycline and medication unknown (Fluid). On an unknown date, the outcome of the injection site infiltration, injection site swelling, skin warm and swelling arm were unknown.   It was unknown if the reporter considered the injection site infiltration, injection site swelling, skin warm and swelling arm to be related to Shingrix.  Additional case details were reported as follows: The patient developed swelling in the injection site similar to an infiltration. The patient stated that it was of great extension and warm to touch. The patient experienced swollen up arm. The patient did not remember the address of the store, where he received vaccine. The reporter requesting consent to follow up.
Extreme fatigue; headache; loss of appetite; lasted more than seven days, with improvement. First time with combined flu shot and pneumonia shot.
his is a spontaneous report received from a non-contactable reporter(s) (Physician). A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Unknown if patient received other medication in 2 weeks. She had no Known allergies. The patient received Paxlovid orally as COVID 19 treatment on 03Aug2022 to 06Aug2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A non-serious spontaneous report of 19 month old child inadvertently received a dose of H1N1 and mild cold has been received from a health professional concerning a 19-month-old male, subsequent to H1N1, Intranasal. The patient does not have history of asthma and no relevant medical history. The patient was not taking any concomitant medication and patient is vegetarian. On 12-Jan-2010, the patient received H1N1, Intranasal, for an unknown indication. On 24-Jan-2010, at night, the patient had symptoms of mild cold. At the time of report, on 25-Jan-2010, the patient was doing well with eating and playing. The outcome of the vaccination error was considered to be resolved and the event of mild cold was resolved on the 25-Jan-2010. Additional information was received on 25-Jan-2010 and incorporated into the narrative: Added one event of mild cold and its outcome, reporter type, patient's gender and concomitant medications. Other information received are country, initials, DOB of patient and reporter's name, address and phone number.
SIDE EFFECTS; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (SIDE EFFECTS) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (SIDE EFFECTS). At the time of the report, VACCINATION COMPLICATION (SIDE EFFECTS) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medications were not provided.; Sender's Comments: There is limited information provided in this case.  In addition to the missing onset and vaccination dates, the symptoms were not described.  Hence, it is not possible to assess this report at this time.  Additional information is being requested
pt had elevated temp (104) & screamed most of noc;mom reported it was a high pitched cry;
Swelling, redness and pain at injection site.  Not feeling well (malaise) Advised ice pack to soothe, NSAID if continued discomfort
By Noon she noted that her right arm was painful and the pain worsened as the day wore on. By 2 PM she began to chill and by 4 PM she ached all over. She felt as though she had a fever but did not take her Temp. She believes she may have taken a dose of  Ibuprofen and went to bed by 7 PM. She slept fair, getting up in the night to the Bathroom 2 or 3 times compared to normally getting up 1 or 2 times. The next morning the arm continued to ache and she still felt lousy in general. She continued to be fatigued and still did not feel well. That night she slept better and by Noon the following day (10/07/16) she began to slowly began to feel better. It took a full week for the arm to finally recover, with the pain gone. The client did not ever notice if the arm was swollen or reddened. Client felt she had fully recovered one week later.
Patient received pfizer vaccine on 10/6/21 and 10/27/21. Presented to ER on 3/6/22. Found to be COVID positive.  Presented to the emergency department secondary to acute right ankle fracture. She was found to be COVID positive.  She is fully vaccinated and remained completely asymptomatic. Not treated for COVID19. Discharged on 3/16/22
This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient stated that she received the Pfizer-Biontech Covid19 on 27Apr2021 and "was crazy sick" for 4 to 5 days afterward. She reported that her "whole body hurt" and she "couldn't find a comfortable position to lay in".   The patient indicated that her symptoms have resolved, but she was  nervous about receiving the second dose.  The outcome of event was resolved on unknown date.   No follow-up is possible. No further information is expected. Information about lot/batch number cannot be obtained.
March 19 Herpes simplex outbreak left mos pubis, mild symptoms; diminished by March 21.  Followed by mild  pre-outbreak nerve sensitivity around the waist. Late in the day March 22 brought the onset of sharp right facial pain  extending from the chin to ear with sensitivity extending to top of the scalp (right side).    Pulses of shooting pain extending from the jaw to ear and temple (right side) kept me awake for most of the night.  The pain subsided somewhat over subsequent days.  Having had shingles at age 24 I suspected that this was the cause, but also  (despite no indication that this was related to a sinus infection) I proceeded with daily salt and betadyne solution sinus rinses just to be cautious.   March 23 noted presence of  sores inside my mouth, lining the inside jaw below the molars.  Over time blisters appeared further back and small sores were present on the roof of my mouth.   By March 28 I was tired of the facial and mouth pain, which now was extending to my tonsil and tongue base at the back of my mouth.   Sought medical care.
Woke up on 10-22-12 3AM with welps all over body (above knees) also lower lip swollen. Encouraged to come to HD now, ER if SOB and see PCP to see if he thinks flu shot related.
Zostavax on Wed - Thurs welt on leg (LT) hot dog size - Fri tennis ball welt - recommended doc call, Benadryl, ice.